Management of the training and

competency of personnel in GxP

and research environments

Part 1: An introduction to training systems

 X

Published by
Research Quality Association
3 Wherry Lane, Ipswich
Suffolk, IP4 1LG
UK

November 2015
ISBN 978-1-904610-36-6

Copyright 2015
Research Quality Association
All rights reserved
Foreword

The Education and Training Committee of the Research Quality Association (RQA)
has been helping shape the Associations training and education strategy.
A subgroup of the Committee has been tasked with developing a best practice guide
for training and development of personnel working in good practice (GxP) regulated
environments. This guide is also intended for those working in non-regulated
environments, who may find the ideas introduced useful in shaping their training
systems and processes and developing best practice GxP-compliant frameworks.

The guidance is directed towards trainees, management and trainers, and anyone
else involved with training and development. It is based upon the pooled knowledge
and resources of the authors and reviewers working in Contract Research
Organisations, the health research environment and the pharmaceutical industry.

Personnel receiving and seeking training make a choice. They either passively
receive mandatory training and information, or actively engage in developing
their training and competency programmes, or a mixture of both. However, by
engaging in their own training and development they are more likely to benefit from
it and demonstrate that benefit by applying the learning to their everyday roles,
responsibilities and tasks. Others, such as trainers, may communicate those learning
outcomes and benefits, further adding value to the organisation and fostering a
quality improvement culture.

We invite you to make your choice with us!

1
 Scope and objectives Acknowledgements

This introductory booklet contains the core ideas This booklet has been developed by the following
underpinning the development and management members of RQAs Education and Training
of effective training, development and competency Committee:
systems and programmes, however small or large.
Katarina Eghan Yasser Farooq
It discusses the drivers behind and principles of
training, development and competency management. Linzi Gillbanks Alison Hunter
It also touches upon the various training
Louise Mawer Belinda Pierce
methodologies and contains some useful tips for
trainers. This first booklet will be followed by Part 2 Jennifer Wilkinson
which will focus on more advanced ideas and will be
of interest to colleagues who would like to know not Additionally, Carl Lummis, RQAs Coordinator
just the what, but also more of the how and why (Learning & Development), was instrumental in
of training-related matters. progressing the booklet through to publishing.
Valuable support and direction were also provided
This guidance has been developed with best practice
by Lee Monk, the Education and Training Committee
in mind and it is intended that the reader considers
Chairman.
the context of how this guide fits within their own
individual organisational structure and needs. Those
new to the concepts can use the ideas to shape their The authors would like to extend their gratitude to
own understanding of the principles of training and the following external contributors and reviewers:
competency management. Sarah Jones Catherine Nelson
This guide aims to provide a solid overview of a wide Sara Parish-Wall Sian Thornley
topic in just a few pages. It comprises outlines of the
principles and best practice, supported by tools such Fiona Waddell Andrew Waddell
as example forms and templates that can be adapted Louise Weber Kath Williams
for use within your own organisation. A glossary of
terms used throughout the booklet has been included and RQA committees supplying regulatory
to aid common understanding of the terminology. knowledge.
Additionally, the booklet contains useful resources for
further reading.

2
Contents
Foreword 1
Scope and objectives 2
Acknowledgements 2
1 Introduction to training and
competency management 4
1.1 Purpose of training and development 4
1.2 Organisational and individual need
for training 5
1.3 Outcomes of training 5
1.4 Training evaluation and assessment 5
1.5 Procedural and other related
documentation 5
2 Identifying organisational training
and competency requirements 6
2.1 Competency management systems 7
2.2 Training management systems 8
3 Roles and responsibilities in training
and competency management 9
3.1 The role of a trainee 9
3.2 The role of management 9
3.3 The role of the trainer 10
3.4 The role of a mentor/coach/buddy 10
4 Developing training and competency
programmes 11
4.1 Training/development/competency
programme/plan 11
4.1.1 Mandatory training 11
4.1.2 Role-based/role-specific training 11
4.1.3 Needs-directed training 12
4.2 The training life-cycle 12
4.3 Competency assessment at
recruitment 13
4.4 Competency levels at employment 13
4.5 Induction/orientation programmes 13
4.6 Analysis of individual training and
competency needs 13
4.6.1 Gap analysis 14
5 Training toolbox 15
5.1 Job-related experience 16
5.1.1 On-the-job training 16
5.1.2 Cross-training 16
5.2 Face-to-face training 16
5.3 Computer-based training 16
5.3.1 E-learning 16
5.3.2 Simulator/video training 17
5.3.3 Webcasts/webinars/
teleconferences 17
5.4 Self-learning 17
5.5 The future of training delivery? 17
6 Training assessment and evaluation of
training and competency programmes 18
6.1 Evaluation at organisational level 18
6.1.1 Ongoing metrics review 18
6.1.2 Periodic operational review 18
6.1.3 Audit 18
6.1.4 Ad hoc 18
6.2 Evaluation and assessment at individual
level training plan and trainee 19
6.2.1 Training plan evaluation 19
6.2.2 Trainee perception evaluation 19
6.2.3 Assessment 19
Appendix 1 Main regulatory
requirements/guidelines 20
Appendix 2 Trainers toolbox 22
Ensure your training is relevant 22
Avoid too much hand-holding 22
Create learner-centric experiences 22
Lose control 23
Choose your delivery carefully 23
Hold the trainee accountable for their
own learning 23
Appendix 3 Example templates 24
CV template 24
Job/role description template 26
Training/learning record template 28
Training programme/plan template 29
Training and competence log template 29
Training record review template 30
Annual training record review template 30
Appraisal template 31
<Year> performance review 31
Performance development plan template 32
Glossary and definitions 33
Abbreviations 34
References 34
Further information and additional reading 35
3
 1 Introduction to training and
competency management
1.1 Purpose of training and
development
Before we can consider the broader aspects of
training and development, it is important that we
understand the difference between training and
learning.
Learning is the acquisition of skills and knowledge
through training, education and experience.
Training seeks to impart a set of skills with a
specific outcome, without the necessity of the
trainee to understand why they need to act in
a specific way. (Compared to education which
results in an individual having learnt skills and an
understanding why actions are taken).
Therefore, in order to ensure competency is gained,
these elements cannot be considered without
the other.
In addition to skills and knowledge gained through
training and education, attitudes and behaviours are
also important elements that have to be considered
in holistic approaches to individuals training and
development. The outcome from successful training
would be an individual with a skill (technical or soft
skill e.g. communication, leadership or performance
management) and the associated knowledge and the
ability and willingness to apply that skill (attitude and
behaviours) to undertake their role to the required
performance standard (competency).
Value added training
Evidence of return on investment (ROI)
Efficiency
Clear Clear
business learning
goals goals
Evidence of competency
Source: Covance learning and performance team
4
GxP regulations and guidelines make it clear that
training is fundamental to the good practice quality
management systems (QMSs). (See Appendix 1 for
detail on the relevant requirements.) Furthermore,
GxP regulations and guidance place responsibilities
on management to ensure there is a sufficient
number of staff with adequate education, skills and
experience to perform their tasks. However, training
and education are driven by organisational needs
as well as those of the regulations. Best practice
also dictates a responsibility of the individual for
ownership of their development plans, identifying
training needs, ways in which those needs can be
met, and development targets to help them become
high performing individuals.
Establishing a robust competency and training
framework need not be a big job; there are no
regulatory prescribed ways to achieve the end
goal: competent and engaged teams and individuals.
This gives each organisation flexibility to ensure the
practices developed are fit for purpose and based
on each organisations needs, wants and individual
circumstances.
Evaluation to Assessments to
monitor monitor
business goals learning goals
Effectiveness
1.2 Organisational and individual need
for training
According to the Business Dictionary (2015), training
is defined as Organised activity aimed at imparting
information and/or instructions to improve the
recipients performance or to help him or her attain a
required level of knowledge or skill.
Before training plans can be developed, it is important
that the following questions are considered:
Organisational need: What are we training staff
for? What is the organisational need or skills gap
identified? What is the risk of not conducting the
training?
Persons need: Who will receive training and what
is their existing level of knowledge or skills?
Task: What specific tasks are required to be
performed and what is the required skill level?
Performance: How do we ensure staff work to an
acceptable standard? Is there a need for retraining
for those with a shortfall in skills or performance?
Legal/regulatory requirements: Is training aligned
and doesnt contradict legal or ethical standards?
Suitability: How will the training be delivered and
how will we know if it is effective?
Cost: What is the return on investment, both to
the individual and the organisation?
Only when the above questions have been
considered can training plans be deemed robust and
add value to both the organisation and the individual.
If there is nothing to change, perhaps training is
not necessarily the solution. In a situation such as
this, it may be acceptable to provide information
regarding the task, based on previous experience
and a demonstration of competency (proof) that an
individual already possesses the necessary skills and
knowledge (e.g. during refresher GxP training).
1.3 Outcomes of training
Learning is about creating a change: improving
the current level of skill, knowledge, attitude or
behaviour. The provision of training is not about
identifying training courses, but appreciating that it is
a personal learning experience, putting the needs of
the individual into context and making training timely
and relevant to organisational objectives and personal
development goals (typically outlined in a personal
development plan). Individuals should be active in
their development and training, and there should be
objective measures of effectiveness to check that
the training delivered a successful and compliant
outcome for the individual and the organisation.
For training to be seen to be effective there must be
an observable or measureable impact that assists
the organisation in achieving its goals and strategy,
whether that is regulatory compliance, improved
processes, reduced error rates or repeat work.
1.4 Training evaluation and assessment
Training evaluation and assessment are an integral
part of all robust training strategies.
Evaluation is measuring the success of the
training on achieving the desired learning
outcome and objective and meeting the desired
organisational need.
Assessment is measuring whether a participant
has achieved the desired end result and is
competent.
Learning evaluation (Kirkpatrick, c2009-2015)
Level 1 Did the delegate like it?
Reaction
Level 2 Did the delegate learn?
Learning
Level 3 Did the delegate use it?
Behaviour
Level 4 Did the training impact the
Results bottom line?
What is the return on the
ROI learning investment?
Source:
http://www.kirkpatrickpartners.com/OurPhilosophy/TheKirkpatrickModel
1.5 Procedural and other related
documentation
As with other aspects of regulated activities, training
and competency management-related processes and
procedures are required to be well defined within
the organisations QMS in, for example, Standard
Operating Procedures (SOPs). The processes for
determining training needs, delivering the training
and evaluating its effectiveness must be clearly
described and followed. Objective evidence that the
processes have been followed and their outcome
was successful must be retained and made available
for review (e.g. by regulatory authority inspectors,
auditors, management or trainers). Appropriate
archiving of documentation is required following an
employees exit from the organisation.
5
 2 Identifying organisational training
and competency requirements
We

find that firms that invest in workforce training
tend to have higher productivity
Most organisations would agree that their staff are
their most valuable resource and they therefore invest
in their staffs training and development.
Thus, the objectives of any organisations training and
development policy will enable staff to:
Acquire the knowledge and skills to enable them
to perform effectively in their roles.
Enhance their performance.
Respond effectively to the demands placed
upon them by internal and external changes and
developments.
Develop their careers effectively within the
organisation and beyond.
When an organisation develops staff training
objectives it is important that wherever possible,
the criteria by which the trainee can be considered
competent following the training can be considered
to be SMART (Specific, Measurable, Achievable,
Realistic and Time-based).
Adult learning cycle
Experience
Application
learning cycle
Generalisation
6
(Cheese, 2015, p.2)
Therefore, the responsibilities of the organisation
include:
Ensuring that individuals have regular opportunities
to discuss training and development needs
(and reflect on courses already taken) with
management/trainers/mentors.
Establishing priorities in relation to competency
and training and making appropriate provision
to meet them within the resources and
budgets available.
Considering training needs which will assist
staff to respond effectively to internal or
external changes.
Helping identify appropriate opportunities for
training and development.
Making appropriate provision for the release of
staff from their duties to undertake training.
Ensuring equal opportunities to access training
and development.
Ensuring time for post training that the individuals
have the opportunity to put into practice what
theyve learned.
Reflection to allow all parties to consider the
journey taken and the lessons learned.
Adult Reflection
Commonly, the same type of training is provided to
individuals involved in conducting an activity (e.g.
the conduct of a clinical trial, the manufacture of a
medicinal product or working in a specified area or
laboratory) without considering if similar training has
previously been received by the individual (perhaps
as part of another trials set up, in relation to a
similar product recently manufactured, or similar
test methodology). A tick is often marked in the
individuals training record to confirm that the training
has been imparted to the individual, but it is not
always followed by the individuals (self-) assessment
of their ability to perform a particular task/job, based
on the training provided. Individuals tend to be the
recipients of training and information but emphasis
is not often given to their involvement in the
development of their training programmes and self-
assessment of their effectiveness (i.e. competency).
Quality by design principles of quality management
offer an alternative to a tick box approach to the
signing off of training records and these principles
have been taken into account when developing
this guide. (Refer to section Further Information
and Additional Reading for further resources on the
quality by design topic).
Examining the organisational needs and objectives
against the skills and training needs of the
individual is commonly discussed during Personnel
Development Reviews (PDRs) or appraisals. The
PDR or appraisal is a planned meeting between line
management and the individual in which (typically)
Components of competence (Rail Safety and Standards Board Limited, 2013)
Components of competence (Rail Safety and Standards Board Limited, 2013)
Technical skills and
Non-technical skills
underpinning knowledge
Technical skills and
Non-technical skills
underpinning knowledge
Competence
Source: Components of competence Adapted from RSSB: Good practiceCompetence
guide of competence development
Source: Components of competence Adapted from RSSB: Good practice guide of competence development
an evidence-based evaluation of past performance
within a defined period takes place (successes and
areas for improvement are both considered). This is
a two-way process whereby goals and objectives
are developed and agreed by both parties. This
results in a forward-looking plan of actions, including
personal development and training targets. When
training objectives are established they can be
structured into a training plan that helps identify how
to meet the objectives and estimate the financial and
resource costs. At the start of employment, goals
and objectives are typically defined in an induction
programme/plan.
2.1 Competency management systems
In order to fulfil the organisational responsibilities and
achieve the organisations objectives, the concept of
competency management is often adopted. There is
no consensus on an agreed definition of competency
(we have included a suggestion for such a definition
in this booklet section Glossary and definitions) but
the dimensions of competencies are generally seen
as demonstrable and assessable, based cumulatively
on knowledge, skills and behaviours required to
perform a particular job to a pre-determined standard.
Key competencies are often used in the creation
of an organisations recruitment and selection
procedures in the form of job descriptions
(Ref. Appendix 3).
Functional skills
Functional skills
7
 Typically, the analysis of competency requirements
would identify:
Competencies needed to implement the overall
strategy of the organisation.
Specific tasks carried out by individual staff
members.
Competencies required to carry out those tasks
effectively.
Available competencies within the organisation,
i.e. existing skills.
Gaps where the identified required competencies
are mismatched against the existing skill sets
(Gap Analysis).
How competencies will be measured.
Measures taken to implement or contract the
required training to develop the competencies.
Communication mechanisms to ensure
organisational and individual understanding of
the competencies, gaps and actions taken in
remediation (when necessary).
Competency management
Define Assess
job role competency
8
2.2 Training management systems
Training Management Systems are typically part
of the competency management systems and are
used to implement any training plan by managing
training requirements, work experience, qualifications
and assessments of individuals in an organisation.
Training is based upon needs or requirements, the
catalyst for which can be:
Additional new staff employed.
Any changes to regulations or introduction of new
regulations.
Role changes by staff, either temporary or
permanent.
Revisions to the organisations processes or
equipment renewal or modification.
Monitoring, review, audit or regulatory inspection
identified problems.
Staff changes that require or prompt re-training or
refresher training.
Continuous professional development and training
of existing staff.
Training Needs Analysis (TNA) can be used to
formally identify the above in a timely manner. The
TNA should detail how any training is designed,
delivered, evaluated and recorded. This will
determine whether the training is required, it will be
within budget, and meets the overall strategy of the
organisation.
Risk-based Training Needs Analysis identifies how
risks that are associated with tasks can be minimised
through learning, assessment and competence
management activities, and used to support decisions
relating to competency and training.
Determine Close gaps
gaps by
developing
3 Roles and responsibilities in training
and competency management
3.1 The role of a trainee
I wonder what
training I am
going to receive?
It is important to acknowledge that training and
development programmes should have the individual
at its centre. It may be considered natural or even
acceptable in a heavily regulated environment to have
complex training plans to verify the individuals ability
to perform a job. This may not be optimal for the
organisation when considering the organisations
resources and financial budgets. Internal and external
(self-) inspections, audits and quality control activities
often uncover non-compliances/deviations/non-
conformances (for example with protocols, SOPs and
manufacturing standards), which are often attributed
to human error.
To foster individual engagement and promote
continuous improvement, it is desirable for
individuals to be involved in designing and evaluating
their own training and competency programmes
(with the support of management, Subject Matter
Experts (SMEs), mentors and peers), and for them
to actively self-assess and critically appraise the
training received.
3.2 The role of management
In the GxP environment, management oversight of
different aspects of the organisation is commonly
mandated by regulation and/or associated guidelines.
In the case of training, management should be an
enabler; helping to source, develop and deliver the
right type of training by optimal means.
Managements focus should be on ensuring that they
provide the necessary resource to support their staff
and help them develop in a number of ways, be it
knowledge, technical, managerial or soft skills. There
are different learning styles that individuals possess
and the one size fit all approach generally does not
work very well.
Management have a responsibility for checking
the understanding and competency of their direct
reports. Mechanisms to achieve this include (but
are not limited to) one-to-one discussions following
training, confirmation by examination (either during
or following the training), peer review or on-the-job
feedback from SMEs or mentors.
Management also have responsibility for supporting
trainers. Training takes time and resources during
the planning, delivery and assessment phases.
Management should take this into account, especially
whenever a trainer has a dual role within an
organisation.
Leadership is everything! When we implement
quality systems, success is directly proportional to
the actions of the top management. The same is true
in training. Organisations which show the effects
of training, education and learning through sincere
practice benefit at the expense of those who see
training as a necessary evil.
9
 3.3 The role of the trainer 3.4 The role of a mentor/coach/buddy

Processes and
Procedure Training

Trainer: Jane Doe

Trainers are an important part of the training To help an individual with their orientation in a new
process. Good trainers impart their knowledge and job role or when they are being trained on a new
experiences whilst also stimulating an individuals process or to plan out an individuals long-term career
yearning for more information and personal path, it is always desirable to identify (an) experienced
excellence. Trainers should thoroughly know the person(s) to help them on their way. These include:
topic or task that they are training on, either being
Mentor usually supporting an individual in
the SMEs or working closely with such individuals to
their medium to long term career planning and
ensure the accuracy of the materials presented.
other personal development areas (mentors are
Trainers need to have the required qualities not necessarily from the same work place) and
and desire to train others. They need to understand typically there for the long term.
the underlying regulatory and organisational Coach usually supporting an individual in their
requirements and expectations, and be able to break more immediate needs, be it in a new job role or
them down into digestible fragments suited to the during performance improvement and typically of
different learning styles and needs. a more senior level within the same department or
Consistency in achieving training objectives and work area.
outcomes amongst trainers is another important Buddy usually supporting a colleague of the
aspect; it is good practice for an organisation to same seniority level.
develop standards and mechanisms for ensuring
Mentors, coaches and buddies are not necessarily
training is effective, engaging and meets the
trainers but they have an important role to play
organisational and regulatory needs in a timely
in helping an individual find their place within the
manner, and in accordance with the financial budget.
organisations structure. They make the process of
Ongoing training of trainers and evaluation of the
doing so less intimidating and assist with short,
training practices, for example mode and frequency
medium and long-term career plans, or other personal
of delivery and target audience, should also be
development areas.
normal practice.
A mentor, coach or buddy is ideally placed to identify
Dedicated trainers have the possibility to influence
training needs and point the trainee in the right
processes and procedures and help develop tailor-
direction when designing their learning journeys.
made training and development packages for staff,
including robust training outcomes. However, it is
not always be possible to have such individuals within
teams and organisations and, as a result, others
need to adopt principles that dedicated trainers
would use. On the job trainers are not necessarily
fully dedicated to training, however, they should be
supported, developed and engaged in the same way
as dedicated trainers.

10
4 Developing training and competency
programmes
4.1 Training/development/competency
programme/plan
The development of training and competency
programmes in a GxP environment, research
environment, or other type of QMS, commonly
requires consideration of both technical and personal
development skills which should be directed to the
needs of the individual, whilst meeting the minimum
requirements of the organisation in consideration
of policy, procedure, culture (including the ethical
context) and regulation, as well as the available
budget and resource.
Competency assessment, whilst a potentially
complex process, in principle is simply confirmation
that the person engaged in training meets the pre-
defined acceptable standards of performance and/
or level of understanding. Additionally, in the GxP
environment, it is common for competency levels
to be defined in technical terms which include (but
are not limited to) a basic (entry level), intermediate
and advanced level (commonly SME, Technical or
Scientific Expert).
These competency levels are often included in
job descriptions and may be linked to promotional
opportunities, but they are in general linked to
personal development processes.
For each competency level, an individuals capability
can be further defined, for example:
Supervised: able to perform the task under
supervision subsequent to certain criteria
being met.
Unsupervised: able to perform the task alone
to an acceptable quality standard, without the
need for supervision following assessment of the
competence achieved.
Trainer: of sufficient knowledge, skills and ability
to impart similar knowledge, skills and ability on
others following a suitable training period.
Successful training and competency programmes
include a combination of training media and
opportunities. They include more than the
documented reading of policies, procedures and
on-line training. They should be engaging for the
individual (to encourage compliance), regularly
reviewed, updated and refreshed (to ensure they
remain accurate against company standards,
regulations and organisational requirements), and
up-to-date for the assigned roles, responsibilities and
tasks. (See section 5 for further details.)
In the GxP environment, training commonly falls into
the following categories:
Mandatory training
Role-based/role-specific training
Needs-directed training
These types of training may be given many terms,
for example Core Training, Job-based Training,
Regulatory Training and Personal Development
Training.
4.1.1 Mandatory training
Mandatory training is required to meet regulatory
requirements, such as predicate rules or GxP
regulations, organisational environment regulations,
employment law requirements and Human Resource
Policies, Health & Safety Law and IT usage and
Personal Data Protection/Privacy requirements.
Mandatory training is also required to meet the
company vision/mission and cultural requirements,
which are designed to equip the individual with
the knowledge and understanding of the accepted
organisational norms.
Mandatory training can be assigned at the global or
central level, or more locally at the Organisational
Unit, Department or Country level.
It should be emphasised to staff at all levels
(including Senior Management) that documented
evidence of mandatory training must be maintained.
4.1.2 Role-based/role-specific training
Role-based/role-specific training requirements are
designed to ensure all individuals performing a
specified task or process meet the same minimum
standards, which is defined in technical, legislative or
organisational terms.
For example, administrative staff may be required
to familiarise themselves with documentation style
guides in order to develop documented procedures
or reports in a common format or presentation.
IT staff may be required to familiarise themselves
with the company IT technical specifications and
standards to ensure that the activities they perform
(and solutions they propose) are within company
capabilities, policy and budget or, alternatively, within
a clinical trials unit, all clinical staff may be required
to evidence training in basic life support procedures
within a specified period.
11
 Training directed to a role will vary with the seniority
of the role and tasks to be assigned; those starting
in a specific area (in the absence of directly
transferrable skills) may have more gaps in their
skills and experience. However, where possible,
learning should be phased over the short, medium
and long term, with defined measurable outcomes
and targets in order for development to be tangible
to both management and the individual in training.
Consideration should be given to interim targets and
measurable outcomes when a specific outcome
(such as sign-off to perform the activity unsupervised)
may take a relatively extended period to maintain
an individuals motivation and verify progress (for
example where necessary to management and/or
Human Resources as part of a probationary period).
4.1.3 Needs-directed training
Training directed to the identified training needs
of the individual in consideration of their prior
skills, knowledge and experience, and the roles,
responsibilities and tasks they will be required to
perform routinely. Additionally, needs-directed training
may be identified during ad hoc activities, or when
reviewing the overall skill set of a department or
function where a skills gap is identified.
Training life-cycle
Recruitment
Needs-based
training
Regulatory
training
12
4.2 The training life-cycle
An individuals training and development
requirements within an organisation generally
commence at induction, when it is necessary
to ensure the individual reaches an acceptable
competence standard to fulfil the basic job
requirements as quickly as reasonably possible.
They continue through employment with periodic
review and evaluation as the needs of the
organisation, regulatory environment and strategic
directions change. Additionally, an individuals training
and development needs change as their role (or the
departments function) changes.
Periodic refresher training is mandated by certain
regulations, for example, the current Good
Manufacturing Practice (GMP) requirements of the
United States Food and Drug Administration (US
FDA) laid down in the Code of Federal Regulations
(CFR) Title 21 Part 211 and GxP guidance such as
Pharmacovigilance Quality Management System
expectations defined by the European Medicines
Agency (EMA) Good Pharmacovigilance Practice
(GVP) Module I.
Prior to leaving an organisation, it is prudent for the
employer to verify the records and assessments
it retains on an individual are complete as this is
considered supporting documentation, necessary
to confirm competence when reconstructing
studies or tasks.
Induction/
on-boarding
4.3 Competency assessment at
recruitment
Identifying staff with the appropriate entry-level
education, qualifications, skills and experience
through recruitment processes requires that the
roles, responsibilities, tasks and necessary personal
attributes for a particular job function are defined, and
in the GxP environment, documented. This role and
person specification should be used as a template for
recruitment, and as a standard during the interview
and induction processes.
Assessments include verbal questioning of
experience, written assessments and/or evaluation
through practical scenarios. Those performing
such evaluations should themselves have received
training to provide assurance that the assessments
performed are consistent, unbiased and directed
towards organisational needs, company culture and
(where applicable) regulatory requirements. For
example, in certain GxP environments, staff must
hold specific qualifications, education and experience
to hold named regulatory responsible positions.
4.4 Competency levels at employment
At the point of employment, an employee should be
reviewed against the recommended competencies
for that job role. These competencies will be taken
from an overview of the company and individual
objectives. For staff with prior relevant experience,
and/or transferable skills, early evaluation by line
management, SMEs, trainers and/or a mentor, can
potentially result in a documented evaluation which
may negate or reduce the need to complete the
necessary/full induction training programme. For
example, staff working in a similar role moving from
one organisation to another may require only pointing
towards the necessary information sources and/or
familiarisation with in-house systems and standards,
rather than training from the basic level needed by a
novice employee.
When SMEs with pre-existing knowledge, experience
and technical skills are recruited to an organisation,
mechanisms should be in place to verify and
acknowledge that experience. For example,
management or GxP-specific attestation can be put
in place such as a competency statement and the
induction programme be appropriately tailored.
4.5 Induction/orientation
programmes
Training provided as part of an induction programme
usually includes mandatory training and role-specific
training for successful completion within a specific
timeframe typically aligned with completion of any
applicable probationary period.
Training provided will normally include familiarisation
with mandatory employment conditions, policies and
procedures, in combination with online and on-the-job
assignments and assessments necessary to perform
basic tasks (i.e. for the individual to function at a basic
level in their role, fulfilling an organisational need).
Following on from induction/orientation training,
individuals use pre-defined programmes or personal
training plans to reach competence in the required
activities, skills and tasks which are evaluated at
the next process-defined stage review (for example
during a regular PDR).
4.6 Analysis of individual training
and competency needs
Once the training and competency programme
has been defined, each individuals needs can
be analysed through an assessment of the
existing qualifications, knowledge, skills and
experience against those required to fulfil the roles,
responsibilities and tasks assigned.
The mechanism of assessment may be formal or
informal, however, in either case, the outcome should
be documented with planned remediation for any
shortfalls or gaps identified. Remediation activities
should be discussed and agreed between the
individual, their line manager and (where applicable)
discussed with the trainer and/or mentor. Commonly,
individual training and development plans arise for
the short term (up to 12 months), medium term (up to
3 years) and long term (up to 5 years and beyond) and
would include a combination of mandatory, role-based
and needs-directed training. These activities usually
take place during periodic PDRs/appraisals.
Loss of competency due to periods of inactivity in
a role or task (planned or unplanned, such as in the
event of maternity or paternity leave, pre-retirement
or sickness) should be considered during periodic
reassessments, to ensure staff maintain necessary
competencies or re-train/refresh as necessary.
13
 Analysis of group or organisational needs may
similarly result in strategic training and development
plans to ensure organisational continuity or
organisational development, facilitate succession
planning and enable the workforce to meet future
organisational needs.
4.6.1 Gap analysis
Review of an individuals training needs can be
a cumulative assessment of performance over
time but is typically performed at induction and
regularly thereafter (annually as best practice) in
a GxP environment. This frequency of training
needs, competency and development targets is
recommended in a research environment to ensure
skill sets are maintained and promote innovation.
Methods to assess the training needs of an individual
include (but are not limited to):
Review of stated education, qualifications, skills
and experience in curriculum vitae (CV) against
the roles, responsibilities and tasks of the job
description or role specification.
Exemplified descriptions during recruitment
and induction discussions against known
circumstances encountered in routine activities
and processes.
Discussions with line manager, mentors, trainers
or SMEs.
Formal testing, evaluation or examination.
Self-identification by the individual based on
reflection of previous performance or review of
future project and strategic requirements.
Gap analysis
120%
100%
80%
60%
40%
20%
0%
Required performance
14
Managerial and/or peer review on-the-job.
Forward planning by the organisation (for example
to meet future organisational requirements such
as expansion into a new therapeutic or technical
area, change or introduction of legislation or
similar).
The formality and periodicity of the individuals TNA is
an organisational decision. However, where there is a
specific legislative requirement the assessment may
be formalised to ensure repeatability, consistency
and quality of the process as well as evidence in the
event of audit or inspection.
Evidence which supports the identification of a
training need for an individual or group of individuals
could include:
Repeated departures from, or failures against,
documented procedures/processes.
Peer, managerial or stakeholder feedback
following a period of performance monitoring or
routine interactions.
Gaps in skills or knowledge relative to tasks,
assignments or regulations which is identified at
interview, on-boarding, induction or thereafter.
Self-inspection, quality control, audit or inspection
results.
What training needs does the
individual have to reach the
required performance?
Current performance
5 Training toolbox

IIunderstand.
hear and I forget. I see and I remember. I do and
(Confucius)

Recognising the distinction between the process
of training and the experience of learning is vital
to effective workplace education. Training is the
process the instructor uses, whereas learning is the
experience the learner has and results in the desired
change. Without learning, training is purely going
through the motions.
Before conducting a training event, consideration
should be given to the following points which should
be described in the outline or description of any piece
of training:
Learning/training objectives and outcomes
what is the purpose of the training and what
demonstrable outcomes are expected once the
training is completed, including mechanisms for
effectiveness checks? Training objectives and
outcomes need to be clearly defined for each
piece of training so as to ensure management,
trainees, trainers and others involved in training
are thoroughly informed of the aims of the
training. Objectives must indicate what will be
different as the result of the training and how we
will know that we have achieved the objectives
taking account of skills, knowledge, attitude and
behaviours.
Prerequisites what background knowledge and
skills is the trainee required to have.
Mode of delivery for example face-to-face,
e-learning, a blend of different training methods.
Regulatory requirements and expectations.
Availability and quality of training materials.
Budget constraints.
Time constraints.
Linked qualifications or certifications.
Mode of assessment, if any.
From an individuals perspective, consideration
should be given to the following:
Personal goals and ambitions what makes the
person tick or what might motivate them to learn.
Previous experience both subject knowledge and
skills and emotional barriers to learning that might
help or hinder the learning experience.
Time constraints that might affect the time an
individual can spend in training; consider both
duration and session timing.
The simplest way to understand an individuals
learning style is to be open and ask the individuals
themselves, either before or during the training. Prior
to the training event you can conduct interviews or
surveys to ask participants specific questions that help
you tailor the training event. Another way would be to
conduct pre-training assessment, knowledge or skill
checks to assess the baseline points of individuals.
The most important criterion for effective delivery
of the training material is that it should enable
participants to achieve the learning outcomes. We
need to be aware that different participants learn
differently and that they have different backgrounds
and baseline skills and knowledge. The 70:20:10
Model for Learning and Development is a commonly
used formula within the training profession to
describe the optimal sources of learning. It holds that
individuals obtain 70 per cent of their knowledge from
job-related experiences, 20 per cent from interactions
with others, and 10 per cent from formal educational
events. (Lombardo and Eichinger, 2006).
The models creators suggest that hands-on
experience (70 per cent) is the most beneficial for
employees because it enables them to discover and
refine their job-related skills, make decisions, address
challenges and interact within work settings. They
also learn from their mistakes and receive immediate
feedback on their performance.
Employees learn from others (20 per cent) through a
variety of activities that include coaching, mentoring,
collaborative learning and other methods of
interaction with peers. Encouragement and feedback
are prime benefits of this valuable learning approach.
Only 10 per cent of professional development
optimally comes from formal traditional course
instruction and other educational events.

15
 Learning styles (Rogers, 2001, p.24)

Learning Stage
style associated with Likes Dislikes
Activist Having an Doing and experiencing. Games, Sitting around for too long; working
experience practical activities, anything that alone; theorising; having to listen to
is energetic and involving. others.

Reflector Reviewing the Time to think, observe, take it Being thrown into activity, no time to
experience all in; watching others; solitude think; crammed timetables; lack of
and time. privacy, no time to prepare.

Theorist Concluding from
the experience
To know where something fits
into overall ideas and concepts;
analysis and logic; being
stretched; abstract concepts;
structure, clarity.
Frivolity, mindless fun; wasting time; not
being able to question; lack of a timetable
and structure.

Pragmatist Planning the next Practical problem solving; Anything theoretical; learning that
steps relevance to the real world; focuses too much on past or future and
applying learning. not present.

5.1 Job-related experience 5.2 Face-to-face training

5.1.1 On-the-job training
Experiential or on-the-job training, for example
supervised operation of activities and processes,
tends to be an effective technique for teaching
and training. It can be achieved by activity or
process observation and carrying out a process or
activity under supervision. This can also be a good
introduction to the terminology used within the
working environment.
Demonstrations by experienced and skilled trainers
are an excellent way to teach employees how to
use new equipment or convey a new process that is
demonstrating or walking through the process that
needs to be taught. Mentoring and coaching plays an
important role in this process.
5.1.2 Cross-training
Cross-training in other disciplines or tasks as part of
the persons training and development plan allows
employees with experience (and the necessary
aptitude for training) to share their experience
and knowledge and train others. This not only
enhances employee skills but also contributes to the
organisation which benefits from having employees
who can perform more than one job.
Cross-training provides a better appreciation and
understanding of what other workers do and how
their roles fit in with the work being conducted.
Face-to-face training is still a popular training delivery
method despite the rapid technological advances
we are faced with in todays world. There are many
reasons for such on-going popularity, for example
the ability to discuss ideas in groups and utilising
non-verbal communication. This can result in more
efficient and effective interactions and training
material delivery. However, one may argue that some
of the benefits listed above are equally inherent to
other types of training delivery methodologies and
it is purely down to personal preference and habit.
Naturally, with the globalisation of the work place,
colleagues sitting in different offices across the globe
are unlikely to be able to get together very often to
receive face-to-face training, in which case other
modes of training need to be considered.
As with other types of training, face-to-face training
is about engaging the audience, prompting their
participation and ensuring that they take ownership of
their learning.
Internal training courses are usually designed to
perform a specific skill, job or task. This contrasts to
external courses which often lead to a subjective or
objective assessment or qualification to demonstrate
that the individual is qualified in a particular subject or
to perform a particular job or task. In-house courses
can also be run by external training providers where
group training requirements can be addressed in a
more cost and resource effective manner.

16
5.3 Computer-based training
5.3.1 E-learning
E-learning is an alternative to face-to-face training
that has become increasingly popular in recent times
as it offers a number of advantages. For example,
e-learning is consistent in the manner in which it
is delivered. It has the ability to reduce trainees
learning time, by allowing trainees to learn and
progress at their own pace and produce cost savings:
travel to training venues is not required and training
materials are reduced.
E-learning is particularly difficult to get right. It needs
to be interactive and engaging and it is important to
recognise how the human brain and memory work
(the brains ability to remember increases when
we hear and see something together i.e. similar
to watching a movie or going to an exhibition).
Repeating the behaviour reinforces learning which
increases memory retention.
E-learning is effective at developing procedural
knowledge and knowledge of defined regulations
and guidelines. It can also do an excellent job of
describing when and how to apply knowledge to
various situations. This is achieved through repeated
presentation of facts, using a variety of formats and
presentation styles. The e-learning training delivery
method is particularly valuable in documenting training
completion and training effectiveness assessment,
if required. The latter can be achieved by linking
specific knowledge testing tools to pieces of learning.
Additionally, the evaluation of training (i.e. how the
trainees perceived it) can also be linked to the training
module and data easily obtained in a timely manner.
E-learning allows organisations to give their
employees easy access to learning materials on the
companys intranet or on a training vendors website.
There are many courses available in many different
areas which provide an interactive way for individuals
to work through the required training materials.
Furthermore, training materials are standardised so all
trainees are provided with the same level of detail.
One possible disadvantage of e-learning is that there
is often little opportunity for human interaction, to
discuss the material and any resultant questions with
others or to monitor how the trainee is performing.
However, this is changing and tools such as wikis,
blogs and discussion boards can be used to aid
ongoing communication.
5.3.2 Simulator/video training
Simulator and video training can also be a particularly
powerful way to train individuals in a protected
environment that is using three-dimensional and
interactive technology to simulate virtual reality
and immersing the trainee in a learning situation
while gaining relevant experience. These simulation
trainings are highly effective and give hands-
on experience without the risk of actual task
performance. For example, flight simulators have
been used successfully for years to train airline and
military pilots in critical flying skills. Simulations
are designed to mimic the processes, events, and
circumstances that are relevant to the trainees role.
5.3.3 Webcasts/webinars/teleconferences
A webcast is a video broadcast of an event
transmitted across the internet (Oxford Dictionaries,
2015). The term webinar has also been commonly
used to mean seminars or media presentations or
events containing audio and visual components which
offer interactivity to participants for example Q&As at
appropriate intervals can be included in the session
(Williams, 2012). Teleconferences can also be used
instead of/in addition to the Internet to share audio
material.
Internet-based meetings, presentations, seminars
and other similar types of events continue to grow
in popularity due to their accessibility and flexibility
and relatively low costs as compared to face-to-face
events. Also, they offer the possibility to record the
event for future access (e.g. by colleagues who
were unable to attend the original event), interactive
elements, instant questions and feedback.
5.4 Self-learning
Through self-learning, the individual acquires
relevant knowledge guided by structured materials,
ranging from print to electronic systems. Training
programmes tend to include an element of self-
directed learning in their overall design and delivery,
allowing individuals the freedom and flexibility to
learn on their own terms.
This type of learning complements and reinforces
other, more formal or interactive training activities,
increasing retention of the learned material. It can be
performed continuously, as an integral part of
day-to-day work activity, and places the responsibility
on the individual in planning their personal
development. Self-discipline is required for self-
learning and some training or specific support of, for
example trainers, management or coaches, may be
required in this area.
5.5 The future of training delivery?
The above paragraphs contain some example training
methodologies currently seen in use throughout the
industry. It is important that organisations monitor
the latest training trends and technological advances
and adapt their training strategies accordingly, and in
a timely manner, so as to ensure that the methods
remain relevant and up to date. Furthermore, it is
important to learn from other regulated industries and
cross-pollinate as much as possible.
17
 6 Training assessment and evaluation of
training and competency programmes
In the previous sections we established that
having a trained and competent workforce is
instrumental in an organisation achieving its goals;
that is delivering the required quality product or
service to meet customer expectations, regulatory
requirements, financial and stakeholder objectives.
We also established that appropriate training is an
essential element in developing and maintaining
the competencies that are required to carry out a
particular role to the required standard.
Training and competency programmes can be costly
and resource-intensive, so how does an organisation
determine if the training and competency needs
analysis and the subsequent design, development
and delivery of training and implementation of
competency programmes have been effective?
The evaluation of training and competency
programmes should be an integral part of the overall
process and can take place on different levels:
At an organisational level
At an individual level.
6.1 Evaluation at organisational level
6.1.1 Ongoing metrics review
To monitor ongoing effectiveness of training and
competency programmes, both qualitative and
quantitative key performance indicators (KPIs) may be
tracked to facilitate continuous process improvement.
KPIs measure the effectiveness of the training
received, uptake of training courses offered and/
or performance against the organisations standards
defined in policy, procedure or an individuals training
plan. KPIs focusing on the quantity of training rather
the quality should be avoided such as % reading rate
of procedures.
Examples of KPIs are:
Improved performance versus budget or
reduced costs
Reduced error rates or rework
Enhanced skill levels
% individuals on training programmes versus
optimal numbers of delegates
Participant feedback scores immediately after a
training event
% individuals behind in meeting training plans
Training assessment scores
Course pass rate first time
Individual training course cancellations.
18
6.1.2 Periodic operational review
Training and competency programmes should be
reviewed periodically to evaluate their effectiveness
and to identify opportunities for improvement. This
can include:
Metrics review (see above)
Review of training and competency-related audit
and inspection observations
How well the training and competency
programmes/plans are adhered to
Review training and development processes
including refresher training
External vendor training
Review of the external vendor(s) providing the
training services
Review any training computer systems used to
deliver training.
6.1.3 Audit
Periodic training and competency system audits
may be undertaken by the internal independent
audit function or by an external contractor. Internal
self-assessment reviews may also be undertaken.
The audit scope may include review of organisation
charts, job descriptions, personnel CVs, review of
training materials and associated documentation,
training records, training and competency procedural
documents and interviews with the training
department (or the individual responsible for the
training process), trainees and their line management.
Audit outcomes will be reported to management and
relevant stakeholders and any required root cause
analysis and corrective and preventive actions are
undertaken as required.
6.1.4 Ad hoc
When there are any changes such as changes to
organisational structure, legislation, internal standards
or computer systems, an evaluation of the training,
and/or training and competency programmes, needs
to take place to assess the impact of the change on
the training needs and to recommend a plan of action
to ensure that organisational objectives can continue
to be met.
6.2 Evaluation and assessment at
individual level training plan and
trainee
6.2.1 Training plan evaluation
Evaluation of training plans will ascertain if training
materials, approach, development and delivery will
produce the desired outcome. Timely evaluation
provides the opportunity to modify and enhance
the training and can identify and mitigate individual
learning gaps.
Resource constraints may not permit evaluation
of all training so many organisations adopt a risk-
based approach to identify those training courses for
which effectiveness evaluations are required. Those
activities critical to the organisation, such as adverse
event safety reporting in the pharmaceutical industry,
are typically subject to such evaluation.
Evaluation can take the form of trainee perception of
training or an assessment of how much trainees have
learned in terms of acquiring knowledge and skills as
an output from the training programme.
6.2.2 Trainee perception evaluation
Trainee perception evaluation normally involves the
completion of a survey or questionnaire, paper-based
or electronic. Best results are obtained if the survey
is administered immediately after the training delivery
to score attributes such as content, mode of delivery,
materials and, if applicable, trainers and facilities. The
aim of these scores and feedback is to determine if
the training met the expectations of the participants
and gave them the knowledge and skills they require
and the confidence to apply the newly acquired skills
in the workplace.
Additionally, the survey can be used to ascertain
information on any barriers to using the new
knowledge and skills. It is advised that review and
debrief of the perception data takes place early
after the training programme so that any necessary
improvements to design, materials and delivery
can be made. Periodic review can then take place
thereafter to ensure continuous improvement and
continued relevance.
6.2.3 Assessment
There are many different methodologies for skills and
knowledge assessment. Additionally, an assessment
of attitudes and behaviours is an important aspect.
The appropriate assessment type is dependent on a
number of factors such as the criticality of the activity
or task being trained, or the training delivery media
and resources. Here is a selection of methodologies
with an explanation of those most commonly used:
Observational assessment: An experienced, trained
and competent assessor will observe the trainee
carrying out a task.
An example of on-the-job training and assessment
is auditor training in the conduct of investigational
site audits in the clinical research setting. An
auditor in training will accompany an experienced
auditor or designated trainer to observe and then
progressively assist in audit activities until they
are at a point where they will be observed by an
experienced auditor-assessor. If deemed to be
competent to conduct an audit independently,
there is then typically a sign-off process. A similar
process is often followed for monitors in clinical
research.
Multiple choice questions or quizzes (paper-based
or electronic): These questions with a number
of answer options are commonly administered
at the end of process-based training where key
knowledge areas are assessed. The aim of these
questions is to determine that a minimal degree of
mastery and/or understanding has been achieved.
These are popular as they are easy to assess,
particularly if the process is automated through an
e-learning module. A pass mark will be set (usually
at 80% or higher) and this must be achieved to
receive a credit for completion of training. For
example, for computer user training, system
access may be contingent on achieving the pass
mark or higher to gain system access. Limits on
retakes may be put in place after which the training
would have to be retaken.
Written examinations: Examinations can be
administered for those knowledge-based training
courses where a comprehensive understanding
and knowledge base is required for example
therapeutic area training or training on legislation or
guidelines.
Other methodologies: Self-paced simulations, oral
questioning, project assignments, aptitude testing
and assessment centres.
19
 Appendix 1
Main regulatory requirements/guidelines

The table below contains examples of the main regulatory requirements and guidelines
pertinent to the training of staff.

Good 
The Organisation for Economic Co-operation and Development (OECD) Principles of GLP and
Laboratory compliance monitoring (ENV/MC/CHEM (98)17) states that test facility management has a
Practices (GLP) responsibility to ensure sufficient number of qualified personnel. Study personnels responsibility
is to be knowledgeable in those parts of the principles of GLP applicable to their involvement in
the study.
 FDAs Title 21 CFR Part 58 states that each individual engaged in the conduct of or responsible
US
for the supervision of a nonclinical laboratory study shall have education, training, and experience,
or combination thereof, to enable that individual to perform the assigned functions. Each testing
facility shall maintain a current summary of training and experience and job description for each
individual engaged in or supervising the conduct of a nonclinical laboratory study.
OECD ENV/MC/CHEM (98)17: http://www.oecd.org/officialdocuments/
publicdisplaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en
US 21 CFR Part 58: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.
cfm?CFRPart=58

Good Clinical International Conference on Harmonisation of Technical Requirements for Registration of

Practices (GCP) Pharmaceuticals for Human Use (ICH) E6 2.8 states that each individual involved in conducting
a trial should be qualified by education, training and experience to performed his or /her
respective task(s).
European Union (EU) Regulation 536/2014 Article 49 Suitability of individuals involved in
conducting the clinical trial states that the investigator shall be a medical doctor as defined
in national law, or a person following a profession which is recognised in the Member State
concerned as qualifying for an investigator because of the necessary scientific knowledge and
experience in patient care. Other individuals involved in conducting a clinical trial shall
be suitably qualified by education, training and experience to perform their tasks.

ICH E6: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
US 21 CFR Part 312.53: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.4
EU Regulation 536/2014: http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG

Good EU Commission Directive 2003/94/EC states that the personnel shall receive initial and ongoing
Manufacturing training, the effectiveness of which shall be verified, covering in particular the theory and
Practices application of the concept of quality assurance and good manufacturing practice, and, where
appropriate, the particular requirements for the manufacture of investigational medicinal products.
 FDAs Title 21 CFR Part 211 states that each person engaged in the manufacture, processing,
US
packing, or holding of a drug product shall have education, training, and experience, or any
combination thereof, to enable that person to perform the assigned functions. Training shall
be in the particular operations that the employee performs and in current good manufacturing
practice (including the current good manufacturing practice regulations in this chapter and written
procedures required by these regulations) as they relate to the employees functions.
Commission Directive 2003/94/EC: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/
dir_2003_94_en.pdf
US 21 CFR Part 211.25: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=211

International ISO based QMSs (e.g. 17025:2012) specify the training and competency of staff; training shall
Organisation for be the responsibility of management and will be relevant to the present and anticipated tasks of
standardisation individuals. The effectiveness of the training actions taken shall be evaluated.
(ISO) based
ISO 9001:2015 requires the determination of competence in the form of knowledge, training and
QMSs experience. Then, as necessary, for organisations to acquire the competence and evaluate the
effectiveness of the actions taken.

20
Good GVP I. C.1.2. mandates that the applicant or marketing authorisation holder should provide
Pharmacovigilance the Qualified Person Responsible for Pharmacovigilance (QPPV) with training in relation to its
Practices (GVP) pharmacovigilance system, which is appropriate for the role prior to the QPPV taking up the position
and which is appropriately documented. In addition Module I.B.7 states all personnel involved in the
performance of pharmacovigilance activities shall receive initial and continued training. Additionally
there are specific modules on the specific training of auditors (GVP IV.B.3.1.2)
and staff members related to Periodic Safety Update Reports (PSURs) (GVP VII.B.7).

GVP Modules: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_
listing/document_listing_000345.jsp

Computer US FDAs Title 21 CFR Part 11 states in part A that FDA will determine that persons who develop,
Systems maintain, or use electronic systems have the education, training, and experience to perform their
Validation assigned tasks.

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme (PIC/S)
section X states that the regulated user is responsible for ensuring all staff who have to perform
tasks in connection with computerised systems are given the requisite training and relevant
guidelines on computerised systems.

PIC/S Good Practices for Computerised Systems in Regulated GXP Environments:
http://www.picscheme.org/pdf/27_pi-011-3-recommendation-on-computerised-systems.pdf
US 21 CFR Part 11: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
US General Principles of Software Validation: http://www.fda.gov/RegulatoryInformation/
Guidances/ucm085281.htm
OECD GLP Guideline for the Validation of Computerized System (Draft):
http://www.oecd.org/chemicalsafety/testing/Draft-OECD-GLP-Guidance-Document-
computerised-systems.pdf

Good 
Personnel engaged in epidemiologic research and related activities should have the education,
Epidemiological training, or experience necessary to perform the assigned functions competently. The organisation
Practices should maintain a current summary of training and experience of these personnel.

International Society for Pharmacoepidemiology: http://www.pharmacoepi.org/resources/
guidelines_08027.cfm#2

Good  Commission Guideline 2013/C 343/01 on GDP of medicinal products for human use states
EU
Distribution that all personnel involved in wholesale distribution activities should be trained on the
Practices (GDP) requirements of GDP. They should have the appropriate competence and experience prior to
commencing their tasks. Personnel should receive initial and continuing training relevant to
their role, based on written procedures and in accordance with a written training programme.
The responsible person should also maintain their competence in GDP through regular training.
In addition, training should include aspects of product identification and avoidance of falsified
medicines entering the supply chain.

Commission Guideline 2013/C 343/01: http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:C:2013:343:0001:0014:EN:PDF

Trials of ISO 14155:2011(E) Clinical investigation of medical devices for human subjects Good Clinical
Devices Practice states that prior to commencement of the clinical investigation, the sponsor shall
ensure documentation of training, experience and scientific or clinical knowledge for all the
relevant parties involved in order to adequately conduct the clinical investigation. Clinical
Investigation Planning states that all parties participating in the conduct of the clinical investigation
shall be qualified by education, training or experience to perform their tasks and this shall be
documented appropriately.

Good Clinical Veterinary ICH Good Clinical Practice (ENV/MC/CHEM (98)17) states that each individual involved
Practice in conducting a clinical study should be qualified by education, training, and expertise to perform
(Veterinary) their respective task(s).

Veterinary ICH ENV/MC/CHEM (98)17: http://www.ema.europa.eu/docs/en_GB/document_
library/Scientific_guideline/2009/10/WC500004343.pdf

21
 Appendix 2
Trainers toolbox
Ensure your training is relevant
Why conduct training if it is not going to be of benefit
to the individual or the organisation they work for?
Therefore, making training relevant is important
to making sure training is going to deliver valuable
results that make a difference.
Relevance must be considered from two sides,
relevant to the organisation and relevant to the
audience. Relevance to the organisation refers to
the impact you intend the training to have on the
organisation and how that impact is going to be of
benefit; this is also called organisational need for
training. Why is the training needed, and how is it
linked to the goals and objectives of the organisation?
Relevant to the individual refers to how the training
and related learning relates to the individual. Is the
trainee motivated to learn the subject, how will it
make a difference to them, also known as WIIFM or
whats in it for me? When a training event is directly
relevant to the learning needs of the individual,
because it is aligned with their goals, objectives and
personal values, that person is far more likely to
engage with the training experience and translate the
training into learning and subsequently into a change
in knowledge, skill, attitude or behaviour. Only when
this happens will the resulting organisational impact
also occur.
In regulated environments, it is also desirable to
review findings from audits, inspections or other
quality issues that can be incorporated in the training.
Furthermore, it can be determined if there are
any attitude or behavioural issues that can also be
focused on during training.
Training should reflect the reality of the trainees
working practices and boundaries, and appropriate
methods to illustrate the point should be used. These
include, for example, storytelling (facts tell, stories
sell) as the learning is far greater if we can relate it to
a funny or intriguing story.
Avoid too much hand-holding
The end result of training or learning must be
reflected in the training event itself. So, for example,
if your end result is to have an individual who can
perform a specific job function in the real world,
without error, then the training must take the
individual the whole way and assess that individual
doing just that. If you intend to hand-hold individuals
in their real jobs then by all means hand-hold
through the learning. If you want staff that are
able, competent, self-sufficient then the learning
experience must reflect this.
22
Create learner-centric experiences
When we are talking about learning we always need
to keep the learner at the centre of everything, since
they are the ones who are required to make the
change. There has been much research conducted
into answering the question of how different people
learn, and therefore how to keep them central to the
experience. Some researchers suggest the decade
a person was born in drives how they prefer to
learn, others suggest there are distinct categories of
learners and others suggest that learning is a cycle
and the position a person starts on that cycle is
dictated by both their previous experiences and their
predetermined preferred learning style. (Honey and
Mumford, 1982; Kolb 1984; Knowles 1989).
All this research is valid and provides great insight
into how and why individual trainees respond
differently during a learning experience. However,
the simplest way to answer this question is every
individual is different; we have all experienced our
own journey to get to where we are today, so every
individual who will need to go through a learning
experience will be different. You might think this
makes the job of the trainer more difficult, and in
some ways it does, but in other ways it makes the
job easier and definitely more enjoyable.
Many think a sheep-dip approach to training will
result in a continuously competent workforce.
Sheep-dip training is where the same training is
planned and administered to everyone in the target
audience without consideration for personalities,
previous experience and existing competency.
Inevitably it fails on many levels: its too much for
some trainees, too little for others and frustrating for
many. Instead when a training event is adapted to the
audience present, focuses on their specific needs and
wants, you create an engaging event. Training events
that are different each time make the job of a trainer
fun and unpredictable, a true facilitator of learning
rather than becoming an actor reciting the same
lines time and time again. However, the end point
must be the same and variability in approach must
be balanced with consistency of message, especially
when training cohorts in the same organisation.
Lose control
The question of who should be in control of the
learning experience and what elements of the training
we should control is often a hard one for regulatory
trainers to grasp. We are programmed to think
control equals quality, so if we want quality learning
surely we need to control the learning experience.
The answer to the control question is actually quite
simple. We should control the output of the learning
experience, but the input and the mechanism to get
to that output should be controlled by the needs
of the individual as far as practically possible. There
must be a clear end result of the learning, something
that is achievable; a skill, knowledge or attitude an
individual changes as a result of going through the
experience; consider these as the learning objective.
There must also be a clearly defined control
mechanism to measure that the end result has been
achieved; consider this the assessment or evaluation
to prove the learning objectives were achieved.
Choose your delivery carefully
For many, the view of a training session is a lecture
style presentation, where the trainer talks through a
slide deck covering all the important information the
trainee MUST learn. We gain this view through our
personal experiences of education, whether it be a
school classroom or a university/college lecture hall.
However, ask yourself if a lecture is a good way to
learn and why did we have to spend so much time
revising before exams? If the lectures gave us all we
needed to learn why did we have assignments and
assessments to complete? The answer is, a lecture is
only part of the experience, its the introduction to the
topic, its not the end its only the start of the journey.
When choosing the delivery method for your training,
it is always important to consider what the trainees
will do and how they will participate in the training
event. What activities are there going to be or
exercises for the trainees to do, questions to answer,
discussions with peers, assignments or case studies
to complete? Always build in active participation
rather than passive observation for the audience to
allow the learner to experience. It is also important
to take into account the intended end result of the
learning, for example do you need the trainee to
understand knowledge or apply a skill?
Dont restrict yourself to the same method, or picking
just one method, consider using blended learning
where you incorporate different learning methods
within the same event to allow a learner to learn,
for example using an e-learning to introduce the
knowledge, followed by an interactive workshop
to apply the skill and finally a workplace assessment
to demonstrate the application of the skill and
knowledge. Remember different learners might
prefer different types of delivery methods.
Hold the trainee accountable for their own
learning
Throughout this appendix we have talked about how
the learner is the one that must have the experience
to deliver the intended results, so the final tips should
come as no surprise. The trainee must be an active
participant in their learning experience so they must
also be accountable for that learning, rather than
being a passive observer.
Accountability is important in a regulated
environment. Accountability and integrity is necessary
for the completion of tasks and duties so why should
training or learning in the regulated environment be
any different? Individuals must own their learning
experience and they must be accountable for the
completion of their learning journey. Accountability in
training can come in many ways:
Self-assessments are a great way to allow
individuals to be accountable for their learning. You
can use self-assessment throughout the learning
event, to identify their starting position, their
progress along and finally once theyve reached
the end of their learning journey.
Other ways of empowering accountability include:
self-directed learning and identification of next
steps to continue their learning. This usually
occurs through a development scheme, or having
a robust career progression map.
23
 Appendix 3 Example templates
CV template

Curriculum Vitae

Name: Insert Name

Job Title: Insert Job Title or Role Function/Specification
Date of CV: Insert Date

Employment History
Current Position
Job Title Company Name, Short Address, Country Start Date: Ongoing

Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks

Previous Positions
Job Title DD Mon YYDD Mon YY
Include previous positions held with this employer.

Responsibilities
Summary of tasks
For similar roles summary of tasks may reference to current position noting increasing responsibility over
time. For different roles, full details may be provided to give an overview of the breadth of experience.
Job Title Company Name, Short Address, Country DD Mon YYDD Mon YY

Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks
Job Title Company Name, Short Address, Country DD Mon YYDD Mon YY

Responsibilities
Summary of tasks
Summary of tasks
Summary of tasks
For GxP positions remember to reflect evidence of experience, qualifications, and skills gained to support an
assessment you are suitably qualified and competent. Include for example specific training in regulations/
guidance, critical processes etc. from previous employers.

Training Courses
[Optional; Recommended for Consultants]
Course Title Provider, Location, Country DD Mon YY DD Mon YY
Course Title Provider, Location, Country DD Mon YY DD Mon YY
Include short summary of courses in the last two years relevant to the position held. Include technical,
regulatory and computerised systems courses or refer to internal training record.

Name Page X of Y Date or Version No.

24
Qualifications/Certificates
Qualification Title Type of Qualification Award Date
Qualification Title Short Summary YYYY

Professional Memberships
Membership Details of Institution/Organisation DD Mon YYDD Mon YY

Languages
Language Level (Native Language, Basic, Proficient, Expert)

Publications
Author Name(s), Year, Title of Paper, Title of Journal/Source, Journal Issue Number: Page Numbers
Author Name(s), Year, Title of Paper, Title of Journal/Source, Journal Issue Number: Page Numbers

Points to Consider:
1. Signature of the document electronically or on printed copy for authentication purposes.
2. Periodic review to ensure details are current; common practice is for review each year with performance
review and/or review every two years.
3. The CV should be updated with significant changes/new information for example change in job title/role
and/or employer, new qualification or membership.

Name Page X of Y Date or Version No.

25
 Job/role description template

Note: Typically produced on letterhead paper.

Job/role description

Job/Role Title: Insert Title

Department: Insert Department Title
Reporting Line: Insert Details of Immediate Supervisor/Line Manager
Name: Insert Name of Individual Assigned to Job/Role
Date: Date Job/Role commenced

Main purpose of the Job

A short summary of WHAT the job is, presented here; for example:
Quality Assurance Professional supporting GxP processes through audit, training, process improvement,
guidance and advice across the research and development organisation.

Areas of responsibility
A short summary of HOW the job purpose is achieved; for example:
1. Audit of internal and external GxP studies, facilities, systems and processes
2. Audit of third parties working on behalf of <organisation name>
3. Development, maintenance and provision of GxP induction and periodic refresher training
4. Project work (as assigned) to support operational teams in the development of new GxP systems and
processes (within and between functions) ensuring regulatory compliance and organisational needs are met
5. Inspection support (during preparation, conduct and corrective/preventative action, and/or follow-up)
6. Designated Archivist

Tasks
A short summary of HOW the areas of responsibility are met; for example:
1. Comply with organisational policy, procedure and applicable regulations
2. Plan, perform, report GxP and third party audits and archive audit-related records
3. Issue audit certificates and statements (where required by procedure and GxP requirements)
4. Maintain GxP knowledge and contribute to the development of GxP systems/processes (when required)
5. Review and maintain training materials in line with current regulatory hot topics and respond to training
feedback to improve effectiveness and delivery of GxP induction training
6. Respond to questions and queries from functional teams within procedurally specified timelines
7. Co-ordinate or lead inspection support teams to ensure timely delivery of information and responses to
inspection-related regulatory authority requests
8. Host the inspection and communicate inspection progress and results in accordance with SOPs
9. Receive records, perform checks and archive materials as per SOPs

Job Title Page X of Y Date or Version No.

26
Note: Commonly the job/role description will also include minimum standards/expectations for experience,
qualifications, skills and/or personal attributes for the job/role.

Personal specification
A short summary of WHAT attributes an appropriate individual will have to successfully
perform the job/role; for example:
Attribute Required Desirable
Experience: 35 years experience in a GxP environment
Experience: At least 2 years audit experience
Qualifications: A science degree or equivalent
Skills: Good numeracy and [English] language skills
Skills: Familiarity with industry standard computerised system
applications such as Microsoft Word, PowerPoint and Excel
Skills: Good written and verbal communication skills
Personal Attributes: Ability to work and travel alone
Etc.

Signed Date

<Post holder name>

Signed Date

<Immediate supervisor name>

Note: There is an expectation within GxP systems that it can be determined from records when
management and the individual agreed the roles/responsibilities assigned to them; this is most
commonly via personally signed and dated job/role descriptions (but can be via alternative records).

Job Title Page X of Y Date or Version No.

27
 Training/learning record template

Individual training/learning record

Name: Insert Name

Job Title: Insert Job/Role Title
Department: Insert Department Title
Reporting Line: Insert Details of Immediate Supervisor/Line Manager
This record does not duplicate information which can be extracted from an electronic learning
management/training record system.

Training Courses/Workshop Attendance

Title Short description/location/duration Date(s)
Example 3-day GCP Refresher training covering electronic data 04-07 Feb 2015
GCP Refresher Training capture systems and risk based approaches to clinical
trial monitoring and audit; London, UK

Self-Learning and Coaching

Title Short description/location/duration Date(s)
Example 2h Reading EU 536/2014 17 Jan 2015
Clinical Trials Regulation
Use of Social Media RQA Webinar, 15 minutes, online 26 Jun 2015

SOPs/Policies/Work Instructions (etc.)

Title Version/effective date Date(s)

Conferences/Symposia/Professional Associations
Summary Short description/location/duration Date(s)

Signed Date

<Post holder name>

Signed Date

<Immediate supervisor name>

Note: Record maintained in an ongoing manner; printed and signed at periodic intervals in agreement
with Supervisor for example at performance review. Alternative template designs contain a signature for
each entry.

Name Page X of Y Date or Version No.

28
Training programme/plan template
Training and competence log template

Training programme/plan

Job/Role Title SOP/Task No.1 No.2 No.3 No.4 No.5 No.6 Task 1 Task 2 Task 3
Role A R&U R&U R&U R&U C C C T
Role B R&U R&U R&U C C C
Role C R&U R&U R&U R&U R&U T
Role D R&U C C C C C C C C

Alternatively:
SOP/Task Job/Role Role V Role W Role X Role Y
No. 1 R&U R&U T
No. 22 R&U R&U C
No. 23 R&U R&U C
No. 24 R&U
No. 55 R&U
No. 237 R&U
Task 1 e.g. Mandatory C C C C
Pharmacovigilance Training (e-Learning)
Task 2 e.g. Mandatory Health & Safety C C C C
Training (face-to-face)

R&U: Read and Understand (R&U) Procedure/Task; generally the minimum training in a procedure
C: Achieve Competency in Procedure/Task; perform the procedure competently unsupervised
T: Develop adequate skills to train others to perform the task competently
Date/Version No.

Training and competence log

Name: Insert Name of Individual Assigned to Job/Role

Job/Role Title: Insert Title
Key to competency level: Level A - Training start date, task performed under supervision.
Level B - Training completion date, considered competent to perform
task unsupervised.
Level C - Assessed as competent to train others.

Competency level
Level A Level B Level C
Skill/procedure trainee* trainer* trainee* trainer* trainee* trainer* Comments**

**Trainer and trainee to initial and date.

**Where a skill/procedure has not been performed within the past year the competency level should be
reassessed. Any changes to the competency level should be recorded in the comments box.

Name Page X of Y Date or Version No.

29
 Training record review template

Annual training record review

Name: Insert Name

Department: Insert Department Title
Job Title: Insert Job Title

Annual review of training records includes as a minimum:

Regulatory GXP training for GCP, GLP and GVP
Completeness of the record
Presence of mandatory training as required by SOP/policy.
I confirm annual review of the following:
Personal
Training plan development Signed by post
CV Job description and records plan holder Date
21 Jan 2014 Version 2 Dated Dated <Insert <Date>
31 Mar 2014 31 Mar 2014 Signature>

Review by Date Review by Date

(e.g. Immediate Supervisor) (e.g. Immediate Supervisor)
<Insert Signature> <Date>

The completeness of the record was verified between the employee and their
line manager on leaving on: DD Mon YYY

Signed Date

<Post holder name>

Signed Date

<Immediate supervisor name>

30
Appraisal template

<Year> performance review

Name: Insert Name

Job Title: Insert Job/Role Title
Department: Insert Department Title
Reporting Line: Insert Details of Immediate Supervisor/Line Manager
Date: Date Job/Role commenced

Review of previous objectives

Completed Partially
Objectives in full completed
Objective 1
Objective 2
Objective 3

Comments:
Explanation/Comment re: partial completion of objective 2

Review of achievements and challenges in <Year>

Achievements Challenges
Summary of successes with evidence (retained/ Summary of challenges with root cause analysis
collected by the individual) by the individual for discussion with focus on
improvement

Training and development considerations

Summary of considerations for short, medium and long-term evaluate past successes and challenges and
support needed for further/continued performance.
What support will be needed in the next 12 months to meet personal and organisational needs? Consider
in-house, external, e-learning, self-learning and face-to-face needs as well as potential conference/symposia/
Professional Association opportunities.

Reviewers comments

Individuals comments

Signed Date

<Post holder name>

Signed Date

<Immediate supervisor name>

31
 Performance development plan template

Objectives for the coming year <Insert year>

Identify objectives for the next 12 months; ensure they are SMART
Specific
Measurable
Achievable
Realistic
Time-bound

Objectives for period <Insert Time Period>

Identify objectives beyond the next 12 months, if relevant; ensure they are SMART
Specific
Measurable
Achievable
Realistic
Time-bound

Signed Date

<Post holder name>

Signed Date

<Immediate supervisor name>

32
Glossary and definitions
Appraisal is a process for individual employees
and those concerned with their performance,
typically line managers, to discuss their performance
and development, as well as the support they
need in their role. Its used to both assess recent
performance and focus on future objectives,
opportunities and resources needed.
 ssessment is the measurement of whether a
A plan goals and whether the plan needs to be revised
participant has achieved the desired end result and is
competent.
Competency is the ability to do something
successfully and efficiently to meet the required
performance standard. Competencies are therefore
demonstrable knowledge and skills coupled with the
right attitude and behaviours. Regardless of training,
competency will grow through experience and the
extent to which an individual learns and adapts
through experience.
Education is the experience of gaining knowledge,
skill or attitude resulting in a change.
Evaluation is the measurement of the success of the
training on achieving the desired learning outcome
and objective.
Good practices or GxPs refer to a set of quality
standards. Examples include the internationally
accepted standards on good manufacturing, good
clinical, good documentation, good laboratory, good
pharmacovigilance and good distribution practices.
Induction Programme/Plan is an important process
for bringing staff into an organisation which provides
an introduction to the working environment and
the set-up of the employee within the organisation.
This programme is often documented in a plan at an
individual, role or functional level.
Learning is the acquisition of knowledge or skills
through study, experience, or being taught.
 earning/training outcomes/objectives are
L
statements that describe significant and essential
learning that learners have achieved, and can reliably
demonstrate at the end of a course or programme.
 rganisational objectives are the overall goals,
O
purpose and mission of an organisation that
have been established by its management and
communicated to its employees.
 ersonnel Development Review is a periodic,
P
structured review of an individuals personal
development plan to ascertain if they have met the
based on changes to personal and organisational
goals.
Quality by design is an approach that aims to ensure
the quality of medicines by employing statistical,
analytical and risk-management methodology in
the design, development and manufacturing of
medicines.
Quality Management System is a set of policies,
processes and procedures required for planning
and execution (production/development/service) in
the core business area of an organisation (i.e. areas
that can impact the organisations ability to meet
customer requirements). ISO 9001 definition.
 efresher training is training intended to revise and
R
update knowledge and skills.
 raining is an organised activity aimed at imparting
T
information and/or instructions to improve the
recipients performance or to help him or her attain a
required level of knowledge or skill.
 raining and development policy is a high-
T
level document which outlines the framework
and governance for the training and development
of individuals and functional groups within an
organisation.
 ersonal Development Plan is an action plan for
P
an individual which outlines the personal, career and
educational goals with corresponding strategies for
learning, training and gaining experience to achieve
these goals.
33
 Abbreviations
CFR Code of Federal Regulation
CV Curriculum Vitae
EU European Union
GCP Good Clinical Practice
GDP Good Distribution Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
GVP Good Pharmacovigilance Practice
GxP Good Practice
ICH International Conference on
Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for
Human Use
ISO International Organization for
Standardization
IT Information Technology
KPI Key Performance Indicator
OECD Organisation for Economic Co-operation
and Development
PDR Personnel Development Review
PIC/S Pharmaceutical Inspection Convention
Pharmaceutical Inspection Co-operation
Scheme
Q&As Questions and Answers
QMS Quality Management System
QPPV Qualified Person Responsible for
Pharmacovigilance
PSUR Periodic Safety Update Report
ROI Return on Investment
RQA Research Quality Association
SMART Specific, Measurable, Achievable,
Realistic and Time-based
SME Subject Matter Expert
SOP Standard Operating Procedure
TNA Training Needs Analysis
US FDA United States Food and Drug
Administration
34
References
Cheese, P. (2015). Foreword. In: Beatson, M., and
Zheltoukhova, K. Productivity: Getting the best out of
people. London: Chartered Institute of Personnel and
Development.
Business Dictionary. Training. [Online]. [Accessed 21
September 2015]. Available from:
http://www.businessdictionary.com/definition/training.
html
Honey, P., and Mumford, A. (1982). The Manual of
Learning Styles. London: Peter Honey Publications.
Kirkpatrick, D. (c2009 2015). The Kirkpatrick
Model. [Online]. [Accessed 21 September 2015].
Available from:
http://www.kirkpatrickpartners.com/OurPhilosophy/
TheKirkpatrickModel
Knowles, M.S. (1989). The making of an adult
educator: An autobiographical journey. San Francisco,
CA: Jossey-Bass.
Kolb, D.A. (1984). Experiential Learning: experience
as the source of learning and development.
New Jersey: Prentice-Hall.
Lombardo, M.M., and Eichinger, R.W. (2006). The
Career Architect Development Planner. 4th Edition.
Minneapolis, MN: Lominger
Rail Safety and Standards Board Limited, (2013).
Good practice guide on competence development.
[Online]. London: Rail Safety and Standards Board
Limited. [Accessed 21 September 2015].
Available from:
http://www.rssb.co.uk/improving-industry-
performance/human-factors/human-factors-case-
studies/good-practice-guide-on-competence-
development
Rogers, J. (2001). Adults Learning. 4th edition.
Maidenhead: Open University Press.
Oxford Dictionaries. (2015). Webcast. [Online].
[Accessed 22 September 2015]. Available from:
http://www.oxforddictionaries.com/definition/english/
webcast
Williams, R.C. (2012). Webinars for Dummies. ON24
Special Edition. New Jersey: John Wiley & Sons.
Further information and additional reading

Quality by Design:
EMA Quality by Design information:
http://www.ema.europa.eu/ema/index.
jsp?curl=pages/regulation/document_listing/
document_listing_000162.jsp
Pharmaceutical Quality for the 21st Century
A Risk-Based Approach Progress Report:
http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
ucm128080.htm
ICH Quality Guidelines:
http://www.ich.org/products/guidelines/quality/
article/quality-guidelines.html
 ompetency and Training Management:
C
http://www.risktec.co.uk/media/47873/
competency%20and%20training%20
management%20guidelines%203.1pdf.pdf
Training needs analysis:
http://www.cipd.co.uk/toolclicks/learning/training-tools/
training-needs-analysis/default.aspx
Self learning:
http://www.open.ac.uk/choose/unison/develop/my-
skills/self-reflection
 he Role of Mentor/Coach/Buddy:
T
http://www.open.ac.uk/about/main/strategy/teaching-
learning-ou
The Training and Development Life-Cycle:
https://cdns3.trainingindustry.com/media/18044506/
training_throughout_the_employee_lifecycle.pdf
E-Learning:
http://www.cipd.co.uk/hr-resources/factsheets/
e-learning.aspx
General learning resources:
http://www.cipd.co.uk/

35
 Notes

36
 Face-to-Face
courses
Our Courses offer the finest standard of training
and knowledge sharing and have developed
in response to the requirements of industry.
Course tutors are drawn from industry and
Government; have wide experience of current
international standards and best practice,
and also the practical application of
these within the workplace.
eLearning
courses
A range of interactive, online, eLearning courses
which provide an awareness of legislation, current
best practice and identify key areas of learning.
All our courses include a SCORM compliant
assessment, and certification upon successful
completion. Courses are accessible on
Desktop and Mobile devices.

01
02

05 Learning
Options
03
Forums
and
Publications 04 Seminars
The RQA produces a range Seminars and Forums
of booklets providing cover and individual topic
guidance on best practice from a specific area with
and information on varied hand picked speakers from
topics. All these booklets industry and Government.
are available in print, and Regional Forums are held
as an eBook. in a geographical area
to enable attendees
to share knowledge

Webcasts and network.

Our on-demand Webcasts cover wide

ranging topics, and are available on all
electronic devices, with an option to
download to Apple and Android mobile
devices to view when you dont have an
internet connection.
Published by
Research Quality Association
3 Wherry Lane, Ipswich
Suffolk, IP4 1LG
UK

November 2015
ISBN 978-1-904610-36-6