The Parenteral Drug Association presents:

2016 PDA Europe Conference

Pharmaceutical Microbiology
Including the Latest Global Updates on Data Integrity,
Contamination Control and Aseptic Processing
22 February
Pharmaceutical
Water Systems

25-26 February
Rapid Microbiological Methods

25-26 February
Charting and Trending of
Environmental Monitoring Data

25-26 February
Control, Validation and Monitoring of
Biofilms in Water Systems

Conference, Exhibition

23-24 February 2016

Hotel Palace

Berlin | Germany
Silver Sponsor

europe.pda.org/Microbiology2016

S C H E D U L E AT A G L A N C E
22 Feb

10:00 16:20

Pharmaceutical Water Systems

Pre-Conference
Workshop

23 Feb
24 Feb

9:00 17:00
9:00 16:30

Conference

Conference,
Exhibition

25 Feb
26 Feb

9:00 18:00
9:00 16:30

Charting and Trending of

Environmental Monitoring Data

Training Course

25 Feb
26 Feb

8:30 18:00
9:00 16:30

Rapid Microbiological Methods

Training Course

25 Feb
26 Feb

9:00 18:00
9:00 17:00

Control, Validation and Monitoring of

Biofilms in Water Systems

Training Course

For latest information, please visit: europe.pda.org/Microbiology2016

2 CHEERS
2 COINS IN A FOUNTAIN
2 FRENCH HENS
2 LITTLE PIGS
GOLDILOCKS AND THE 2 BEARS
2 PIECE SUIT
2 STOOGES
2 BLIND MICE
2 DIMENSIONAL
2 MUSKETEERS
2 TENORS
3 CHANGES EVERYTHING.
Thats why weve added Celsis, International Ltd. to our family of industry-leading brands. Customers have long trusted our Endosafe endotoxin testing and Accugenix microbial identification
solutions to bring their products to market safely and efficiently. Celsis now rounds out the trio,
offering rapid microbial detection systems that make us unmatched in our ability to support your micro QC programs, every step of the way, learn more at www.criver.com/emd.

#Microbiology2016

WELCOME FROM THE CHAIRS

Dear Colleagues,
PDA Europe warmly welcomes you to the 2016 Conference on
Pharmaceutical Microbiology in Berlin, where industry, academic
and regulatory experts will provide you with new insights into current
issues during these two days.
Scientific Program
Planning Committee
Di Morris, GSK, Co-Chair
Paul Newby, GSK, Co-Chair
Sandra Gay, bioMrieux
Heike Merget-Millitzer, Janssen Cilag
Michael Miller, Microbiology Consultants
Johannes Reich, Hyglos
Olivier Rocher, GSK Vaccines
Christian Scheuermann, Charles River
Sylvia Becker, PDA Europe
Falk Klar, PDA Europe

This conference will explore a large variety of topics and approaches

to microbial contamination control, sterile/non-sterile products, biofilm
and pharmaceutical grade water. Furthermore, it will provide an overview of regulatory trends and updates, such as the Annex 1 Revision.
The conference will also focus on new technologies and trends, e. g.
data integrity and quality metrics.
As an attendee of this event, you may expect excellent presentations
held by fantastic speakers, accompanied by poster presentations and
an exhibition that will showcase technologies and trends for pharmaceutical microbiology strategies. Above all, there will be plenty of
opportunities to get in touch and interact with the experts and your
fellow attendees. During morning and afternoon refreshment breaks
you can visit the exhibitors of various companies or meet other industry and regulatory microbiologists. Ample networking will be provided
as you are invited to on-site lunches as well as an evening reception.
In addition to this two-day conference, we also offer a pre-conference workshop and three training courses that will help you discuss
in more detail the new insights gained.
Join us in Berlin for this exciting week to exchange knowledge about
the latest technologies in Microbiology, microbial detection and regulatory compliance!
Welcome to Berlin!

Di Morris, GSK

Conference Co-Chair

Paul Newby, GSK

Conference Co-Chair

#Microbiology2016

PRE-CONFERENCE WORKSHOP

Pharmaceutical Water Systems

Overview
Pharmaceutical water is, perhaps, the most important of all pharmaceutical substances. It is used
as an excipient in many pharmaceutical formulations, as a cleaning agent or as a separately packaged product diluent. Pharmaceutical facilities typically have systems for delivering different water qualities such as Purified Water (AP), Highly Purified Water (HPW) and Water for Injections (WFI).
The Pre-Conference Workshop will introduce compendial requirements for water qualities and
will provide overview information about principles of generation and testing of pharmaceutical
water. Emphasis will be placed upon contamination control. The Workshop will cover construction materials and components used in pharmaceutical water systems and will discuss concepts
for qualification, validation and maintenance. The participants will receive information about
most recent developments using modern techniques and will have the opportunity to discuss
implications on quality and cost.

Mario Rsch, Head of Product Group Highly Purified Media Systems, Pharmatec (A Bosch Packaging - Technology Company)
Mario Rsch joined Pharmatec as Project Manager in 2007. He was responsible for Projects with Purified Medias Systems including Pure Steam Generators, Stills and Purified Water Generators at various pharmaceutical
companies including GSK Wavre, Roche, Novartis. In 2014 he became head of the Product Group Highly Purified
Media Systems at Pharmatec - A Bosch Packaging Technology Company and is responsible for the development
of the product line of the Purified Water Generators at Pharmatec.
Thomas Rcker, General Manager, Letzner Pharmawasseraufbereitung
Thomas Rcker studied industrial engineering receiving his Master degree in international business and engineering in 2005 in Berlin (MBE). His career at Letzner started in 2007 as project manager and engineer for
pharmaceutical water and steam projects. Getting in touch with all products and services offered by LETZNER
he gathered engineering experience over 4 years before changing to the sales department. Since 2011 Thomas
is responsible for sales and marketing. In 2015, he joined the general management. The specialized company
for pharmaceutical water and steam generating technology is internationally expanding with its products Made in Germany
Jochen Schmidt-Nawrot, Head of Energy & Infrastructure, Chemgineering Technology
Jochen Schmidt-Nawrot has over 20 years of experience in pharmaceutical water treatment. After studying process engineering in Stuttgart he has worked for several well-known manufacturers of pharmaceutical water
systems. Since 2 years he is Head of Department Energy & Infrastructure at Chemgineering using his recognized
knowledge for conceptual design and planning of PW and WFI-Systems.

Klaus H. Schreiber, Regional Sales Manager, Pharmatec (A Bosch Packaging - Technology Company)
Klaus H. Schreiber joined Bosch in 1994 where he was responsible in different functions and regions for Sales,
Marketing and later Product Management/Business Development for sterile filling lines and related up- and
downstream equipment. Since 2014 he is the Regional Sales Manager for MENA and Marketing Responsible at
PHARMATEC - A Bosch Packaging Technology Company.

#Microbiology2016

AGENDA
11 Feb 2016

Monday, 22 February 2016

10:00-16:20

10:00

Welcome

10:10

Introduction to Pharmaceutical Grade Water

Introduction to different water qualities according to pharmacopoeias
Overview of water testing methods such as
on-line TOC, pH, conductivity and laboratory methods
Overview of water production principles and equipment

Mario Rsch, Pharmatec

(A Bosch Packaging Company)

10:40

Revision of the WFI Monograph in the European Pharmacopeia

History of membrane technologies for production of WFI
Which changes have been made in the Revision?
Outlook into the future of Pharmaceutical Water Systems

Jochen Schmidt-Nawrot,
Chemgineering Technology

11:10

Coffee Break

11:30

WFI Generation with Membrane Technology

Process and equipment
Material and design
Opportunities and threats
Established technologies for WFI generation

12:30

Lunch Break

13:30

Manufacturing of WFI by Vacuum Membrane Distillation Technology:

Advantages and Challenges
Key properties of equipment
Maintenance

14:15

Coffee Break

14:45

Water Systems Risk and Cost Perspective

Overview of risks and cost implication
Concepts for microbiological control of water systems
Reduction of Total Cost of Ownership

15:30

Panel Discussion

16:20

End of Pre-Conference Workshop

Thomas Rcker,
Letzner Pharmawasseraufbereitung

Klaus Schreiber, Pharmatec

(A Bosch Packaging Company)

Jochen Schmidt-Nawrot,
Chemgineering Technology

#Microbiology2016

PDA Europe supports the children's hospice Sonnenhof

The Sonnenhof Hospice, located near PDAs office in Berlin, offers support and assistance to families with children suffering from incurable and/or debilitating diseases.
At Sonnenhof, children, together with their families, can spend the time they have left as
they wish and find some relief from their suffering.
Instead of purchasing expensive gifts for the conference speakers, PDA has decided to
Logo Sonnenhof - Farbwerte:
donate this amount to the SonnenhofBlau
Hospice.
YouMcan
also
contribute
and help us in= C 100%/
30%/
Y 0%/
K 0%
Gelb = C 0%/ M 25%/ Y 95%/ K 0%

crease the amount, it is easy: buy a package of chewing gums at the registration desk.
THANK YOU!
To know more about the Sonnenhof Hospice, please visit
www.bjoern-schulz-stiftung.de

S ONNENHOF

S ONNENHOF

S ONNENHOF
#Microbiology2016

NETWORKING EVENT INVITATION

PDA Europe is Pleased to Invite You

to a Guided Sightseeing Bus Tour and
Dinner at Brewery Lemke
18:30
START OF THE GUIDED SIGHTSEEING BUS TOUR HISTORICAL PLACES IN BERLIN
19:30
DINNER AT THE BREWERY LEMKE NEXT TO THE SCHLOSS CHARLOTTENBURG
21:30
RETURN TO THE HOTEL VIA BUS TRANSFER

Tuesday, 23 February

Meeting Point: Hotel Palace Lobby

Sightseeing Bus & Shuttle leaving at 18:30
Dress Code: Casual

Please confirm your attendance at the PDA registration desk.

#Microbiology2016

CONFERENCE AGENDA
11 Feb 2016

Tuesday, 23 February 2016

9:00

Welcome and Introduction

Session 1: Current State & Hot Topics

Falk Klar, PDA Europe

Di Morris, GSK, Co-Chair
Paul Newby, GSK, Co-Chair
Moderator: Paul Newby, GSK

9:15

Changes in the EU Guidance Impact of Changes

Di Morris,
GSK

9:45

Revision of Annex 1

Mike Davies,
GSK

10:15

ISO 14644-1 & 2

New Requirements of a Risk Assessment

Marsha Stabler-Hardiman,
ValSource

11:00

Coffee Break, Poster Session & Exhibition

11:30

Data Integrity

12:30

Q&A, Panel Discussion

13:00

Lunch Break, Poster Session & Exhibition

Session 2: Future Trends

Di Morris,
GSK

Moderators: Heike Merget-Millitzer, Janssen Cilag

Johannes Reich, Hyglos

This wide ranging session will consider future trends in a variety of areas including environmental monitoring, VHP sterilization and novel
testing technologies. Presentations will include an outline of the use of oxygen depletion monitoring of pharmaceutical manufacturing
facilities and personnel, and bacterial cell detection using synthetic polymer foot printing and MICROPRINT electronic enzyme profiling. The session will also explore a newly emerging view of biological testing by investigating endotoxin as an Innate Immune Response
Modulating Impurity. A Q&A session will follow which will enable further discussion with members of the expert panel drawn from pharmaceutical manufactures, equipment suppliers and academia.

14:00

Risk-based and Holistic Environmental Monitoring (EM)

14:30

Cycle Development and Validation Guidance for Terminal Surface

Juha Mattila,
Sterilization using Vaporized Hydrogen Peroxide (VHP) at Low Temperature Steris

15:00

A New Rapid Microbiology Method based on Measuring Oxygen Depletion:

An Assay for Testing Surfaces of Equipment, Facilities, and Personnel in
Pharmaceutical Manufacturing Controlled Environments

15:30

Coffee Break, Poster Session & Exhibition

16:00

Detection of Bacterial Cells in Pharmaceutical Ingredients using Synthetic

Polymer foot printing and Electronic Enzyme Profiling MICROPRINT

Eithne Dempsey,
Institute of Technology Tallaght

16:30

Endotoxin as an Innate Immune Response Modulating Impurity

Kevin Williams,
Lonza

17:00

Q&A, Discussion

17:30

End of Day 1 & Networking Dinner Event

#Microbiology2016

James Drinkwater,
Franz Ziel

Claudio Denoya,
PMS

CONFERENCE AGENDA
Wednesday, 24 February 2016
9:00

Welcome & Opening of Day 2

Falk Klar, PDA Europe

Keynote Presentation
9:05

Everything You Always Wanted to Know About Endotoxins But Were Afraid to Ask

Session 3: Contamination Control & Process Environment

Ulrich Zhringer, Research Center

Borstel, Leibniz-Center for Medicine
and Biosciences
Moderator: Falk Klar, PDA Europe

The session will emphasize the general concept of contamination control being based on prevention, monitoring and treatment. It will be
highlighted that a thorough understanding of the overall manufacturing process and the supporting steps is a crucial prerequisite for an
effective and efficient contamination control. Presentations will introduce a holistic approach for the control strategy considering all critical
process parameters and will suggest integration of the control strategy into the overall qualification framework. Possibilities and challenges of contamination testing of sterile and non-sterile pharmaceuticals will be discussed. Special attention will be given to most persistent
contaminations by bacterial and mold spores. A risk based approach will be suggested for the identification of process related pathways for
viable and non-viable particles as well as for the determination of meaningful sampling positions.
9:45

Annex 1:
Non-sterile Products and Control Strategies
Referencing Annex 2 and Chapter 1
What Should a Complete Control Strategy Include?

Di Morris,
GSK

10:15

Control Strategy:
Water Activity in Microbiological Control of Nonsterile Manufacture

Jonathan Willis,
GSK

10:45

Coffee Break, Poster Session & Exhibition

11:15

Solutions for Overcoming Testing Challenges with

Disinfectant Coupon Studies

Jim Polarine,
Steris

11:45

A Risk-based Approach for the Definition of Sampling Sites

in RABS and Isolators based on HACCP Principles

Nadine Staiger,
Janssen Cilag

12:15

Culture Media: Back to Basics

Corinne De La Foata,
bioMrieux

12:45

Q & A, Discussion

13:15

Lunch Break, Poster Session & Exhibition

Session 4: Environmental Data Handling

Moderator: Michael Miller, Consultant

This session will focus on environmental monitoring and in particular, novel technologies for generating viable and nonviable data and
alternative data trending concepts. We will initially review a case study on the use of laser induced fluorescence for the real-time and continuous monitoring of airborne microorganisms and compare these data with conventional particle counters and air monitoring procedures
requiring microbial growth. Next, several case studies will explore trending of environmental monitoring data, originating from pharmaceutical companies producing sterile products, using two approaches: the three-sigma limit approach as well as the guidance provided in USP
chapter 1116, in which monthly and cumulative percentages of contaminated EM samples from all tested samples are monitored as a quality
metric of the microbial monitoring process. Finally, we will discuss this important topic of Data Integrity to close this conference.
14:15

Microbial Contamination Control:

Real Application Cases of RT Detection

Rocco Petrizzo,
TSI

14:45

Charting and Evaluating Distribution-free Environmental

Monitoring Microbial Counts and Contamination Recovery Rates

Raphael Bar,
BR Consulting

15:15

Closing Panel Discussion

Moderator:
Di Morris, GSK

16:00

Closing Comments & Farewell Coffee in the Exhibition Area

Falk Klar,
PDA Europe
#Microbiology2016

COMMITTEE MEMBERS' BIOGRAPHIES

Di Morris, Audit Manager, GSK, Co-Chair
Di Morris is a Chemist, Microbiologist and a Qualified Person. She used to be a Medicines Inspector for the
MHRA and has been working in the pharmaceutical industry for over 30 years. Di has experience in the
areas of Quality Control, Quality Assurance and Regulatory Affairs, covering a wide range of dosage forms
including sterile products, biological, and non-sterile products. Di currently works as an Audit Manager in
the Compliance Audit Group (CAG), Quality Systems and Compliance of GSK.

Paul Newby, SM Manager, GSK, Co-Chair

Paul has worked in the pharmaceutical industry in both research and manufacture roles for the past 24
years. He has been actively involved in introducing new rapid microbiological technologies, project management, microbiological method development and validation and microbiological support of nonsterile
manufacture. Currently, he manages the Pharmaceutical Development UK microbiology teams within GSK
Research & Development. Paul is a member of the BP expert committee on microbiology and has been involved in reviewing
the draft EP chapter on Rapid Methods (5.1.4). He is also part of the PDA technical working party charged with updating Technical Report 33 Evaluation, Validation and Implementation of New Microbiological Testing Methods which was published
in October 2013. Paul has recently developed a microbiological control strategy for GSKs new generation inhaler products
for nonsterile dry powder presentations which reflects the recommendations of USP <1115>. The approach is risk based and
incorporates a novel NIR-based water activity method developed specifically for lactose-based dpi presentations. Regulatory approval is currently ongoing and submissions have been made to European, ROW and US markets.
Sandra Gay, bioMrieux, Global Scientific Marketing Manager Biopharma
Sandra holds an engineering degree and a Masters of Science in Biology. She obtained a PhD in Oncology
at the University of Claude Bernard (Lyon, France). After several years as consultant in strategy and marketing for pharmaceutical and biotechnology companies, Sandra joined bioMrieux as Global Scientific Marketing Manager Biopharma. At bioMrieux, she is today in charge of helping pharmaceutical companies
define and implement next generation microbiology tests complying with regulatory guidelines.

Heike Merget-Millitzer, Senior Manager QC Microbiology & Hygiene, Janssen Cilag

Heike Merget-Millitzer studied Biology at the Technical University in Darmstadt and holds a PhD in Biochemistry from the University in Frankfurt/M. She has more than 15 years of work-experience in aseptic
manufacturing of cell therapeutics and large molecules in pharmaceutical industry. She joined Cilag AG
in Schaffhausen, Switzerland a division of J&J in 2005 where she was managing manufacturing of clinical
supplies, commercial products and new product introduction of sterile drug products into the pilot plant at Cilag AG for
9 years. Since one year she is heading the Microbiology Department of Cilag AG. In her current role she is responsible for
microbial testing of raw materials, API, non-sterile and sterile products manufactured at Cilag AG as well as environmental
monitoring of the production facilities and utilities.
Michael J. Miller, Microbiology Consultants, President
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods.
He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of
new microbiology technologies. Michael currently serves on a number of PDAs program and publication committees and
advisory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of
New Microbiological Testing Methods. Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University
(GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.

10

#Microbiology2016

COMMITTEE MEMBERS' BIOGRAPHIES

Johannes Reich, University Regensburg
Johannes Reich is PhD Student at University Regensburg. His research efforts are focused on the aggregation and interaction behavior of Lipopolysaccharides as well as the related activity in limulus based detection systems. He previously received his Master of Chemistry at the University of Regensburg. In this role,
he worked on Supramolecular Approach of Synergistic liquid-liquid Extraction systems at the Institut de
Chimie Sparative de Marcoule in France. Johannes Reich also received a degree in Business Administration from University
of Applied Sciences in Regensburg, Germany. While pursuing his degree, he worked as Product Manager for the department
Drugs of Abuse at Profos AG for several years.

Olivier Rocher, GSK Vaccines, Head of the QC Microbiology and Sterility Assurance Manager
Olivier obtained a Master Degree in Cellular Biology, specializing in Industrial Microbiology, in Paris and
started his career in 1998 as an R&D Project Leader in Rapid Microbiology. During 5 years within Chemunex,
he developed various protocols using solid-phase and flow cytometry for the pharmaceutical, food and cosmetic industry. He joined Wyeth Biopharm near Dublin, Ireland, in 2003 as a Rapid Micro Specialist to help the
local team with the evaluation and validation of various rapid micro methods. He joined GSK Vaccines in 2006 and is currently
Head of the QC Microbiology and Sterility Assurance Manager for QC Aseptic Operations. In his role, he is accountable for all
microbiological testing of utilities, raw materials, vaccines intermediates & final products, microbial identification and support
to transversal Cleaning-Disinfection-Validation-Sterility Assurance Programs and microbiological investigations on site.

Christian Scheuermann, Charles River Laboratories, Key Account Manager Microbial Solutions for Europe
Christian has ten years of experience from academic and industrial environments. He has been a project
leader and authorised person for biological safety (BBS) according to 15 und 17 of the German Genetic
Engineering Regulation. He has gained experience in leadership, quality management, and in his current
position, he is building a key account/global account management for the European part of the Microbial
Solutions business unit at Charles River. He recently started to also manage sales in Poland as a Regional Account Manager.
These activities require strategic planning, networking with key opinion leaders and expertise in GMP/Pharma, (QC) Micro-/
Molecular Biology. Christian is also the European expert for microbial identification (strain typing) and library building at
Charles River - Microbial Solutions.

Falk Klar, PDA Europe,Senior Director Training & Education

Falk Klar holds a PhD in Applied Physics and has more than 19 years of experience in Quality Assurance
and Compliance. Before joining PDA Europe, he worked for the pharmaceutical, biopharmaceutical, and
medical device industries, and in clinical research. Falk joined PDA Europe in 2015 as Senior Director Training & Education. He will develop and extend PDA Europes portfolio of training courses and workshops for
the parenterals market.

Click for Complete List of Speakers Online

#Microbiology2016

11

FLOOR PLAN
Buffet/Coffee Station
Table Top 2,6m x 1,8m (4,6m2)
PDA Registration

Conference Room
Merck

Assoc.
Cape Cod

Bruker

Lighthouse

Lonza
Mar Cor

Hyglos

Confarma

NSF

Steris

VAI

Haemochrom
Diagnostika

CRL

PMT

biomrieux

TSI

11

17
16

12

#Microbiology2016

12
15

14

13

EXHIBITOR ABSTRACTS

Associates of Cape Cod, Inc. (ACC), is one of the worlds largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (13)--D-glucans. Our products are
used worldwide by leading pharmaceutical and medical device
companies to ensure the safety of their parenteral drugs, biological
products and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service, in our industry to enhance the productivity and efficiency
of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA Inspected and DEA Licensed and our Beacon Diagnostics laboratory is CLIA certified. Our corporate headquarters are
located in East Falmouth, Massachusetts with offices in the UK and
Germany. Founded in 1974 by Dr. Stanley Watson, our company was
the first to be licensed by the FDA to manufacture LAL for use as a
quality control test for endotoxin detection in the pharmaceutical
and medical device markets. Over the years, we have grown to be an
internationally recognized leader in endotoxin detection, with over
150 employees and a distribution network servicing 80 countries.
bioMrieux Deutschland GmbH
Weberstr. 8
72622 Nrtingen
Germany
Tel: +49 7022 30 07 0
Fax: +49 7022 36 11 0
info.de@biomerieux.com
www.biomerieux.de
A world leader in the field of in vitro diagnostics for more than 50
years, bioMrieux is present in more than 150 countries through
42 subsidiaries and a large network of distributors. In 2015, revenues reached 1,965 billion with 90% of sales outside of France.
bioMrieux provides diagnostic solutions (reagents, instruments,
software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its
products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for
detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

Bruker Daltonik GmbH

Bruker Daltonik GmbH
Fahrenheitstr. 4
Bremen, 28359
Germany
ms.sales.bdal@bruker.com
www.bruker.com
As leader in MALDI-TOF technology do we offer high performance
platforms intended for extensive and routine usage in the microbiology laboratory. Within a short period of time, the MALDI Biotyper
system has revolutionised the way that microbial identification is
performed. The speed, accuracy, ease of use and cost efficiency
are so impressive that over 1.500 laboratories all over the world
already employ this system solution for microbial identification
of microorganisms. Applications include clinical routine microbial
identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety as well as
quality control.
Charles River
Domaine des Oncins BP109
69592 LARBRESLE cedex, France
Tel: + 33 474 016 96 9
Fax: + 33 474 016 53 1
eurendo@crl.com
www.criver.com/emd

Silver Sponsor

Charles River, based in Wilmington, Massachusetts, U.S., isa global

provider of solutions that advance the drug discoveryand development process. Combining the expertise of two long-trusted
brands, Charles River pairs Endosafe rapid endotoxin testing systems with Accugenix contract microbial identification services to
offer a complete QC testing solution. Endosafe cartridge technology improves operational efficiencies by enhancing ease of use and
accelerating testing times. Cost-effective microbial identification is
conducted in an FDA-registered lab using the Accugenix DNA sequence library, which profiles more relevant microorganisms than
any other service laboratory in the industry.
Conference, Exhibition, Education Program

1st PDA Europe

2016

Associates of Cape Cod, Inc.

European Subsidiary
PYROQUANT DIAGNOSTIK GmbH
Opelstrae 14
64546 Mrfelden-Walldorf
Germany
Tel: + 49 61 05 96 10 0
Fax: + 49 61 05 96 10 15
service@acciusa.de
www.acciusa.de

Annual Meeting

28-29 June 2016 | Berlin | Germany

#Microbiology2016

13

EXHIBITOR ABSTRACTS
CONFARMA France SARL
ZI, Rue du Canal dAlsace
68490 Hombourg
France
Tel: +33 389 83 37 20
Fax: +33 389 83 37 26
info@confarma.fr
www.confarma.ch
CONFARMA is a CRO since 1972, specialized in R & D, CMC and studies and one of the international leader of scientific services. The
activities of the CONFARMA group comprise analytical chemistry,
Galenics, Stability studies, Microbiology, Biochemistry, Biology,
Immunology, Molecular Biology, Pharmacology-Toxicology. The
phases of development covered by CONFARMA are R & D (contract
research), Preclinical, Clinical (only analytics), Commercial (CMC)
quality control and routine testing. The markets served are Academical Research Institutions, EU collaborative projects, Biotech,
Biopharma, Vaccines, Pharma and Medical Devices. The certification comprises GMP, c-GMP (FDA, no 483), GLP, ISO 9001, ISO 14001,
ISO 17025, OHSAS 18001.
Haemochrom Diagnostica
Renteilichtung 1
45134 Essen
Germany
Tel: +49201843770
Fax: +49201536456
info@haemochrom.de
www.haemochrom.de
Since more than 20 years Haemochrom Diagnostica has been working with haemostasis diagnostics and endotoxin analytics. Within
these areas we supply the market with reagents that play an important role in the pharmaceutical industry, in the university research
area and in the routine diagnostic laboratories. In cooperation with
well known manufacturers Haemochrom Diagnostica offers a wide
product range that is adaptable on all current instrumentation systems on the basis of certified and validated methods. In later years
the international activities were enforced: branch offices in Sweden
and Denmark as well as market activities in Austria, Norway, Finland
and Switzerland make Haemochrom Diagnostica an important supplier in the haemostasis and endotoxin diagnostics market.

Hyglos GmbH
Am Neuland 3
82347 Bernried
am Starnberger See
Germany
Tel: +49 8158 90 60 0
Fax: +49 8158 90 60 21 0
info@hyglos.com
www.hyglos.com
Driving Innovation in Endotoxin Detection & Removal: Our recombinant next-generation endotoxin test assays EndoLISA and EndoZyme bring important advantages to users in pharmaceutical
research and quality control, overcoming limitations of classical
methods. Hyglos team of dedicated scientists has also developed
a new sample preparation method, the Endo-RS, enabling robust
endotoxin testing in surfactant-containing biologics affected by Low
Endotoxin Recovery (LER) addressed by the FDA.
LIGHTHOUSE Instruments
Science Park 408
1098 XH Amsterdam
The Netherlands
Tel: +31 6 20 17 65 02
euinfo@lighthouseinstruments.com
www.lighthouseinstruments.com
LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace inspection systems. Headspace applications
include among others: automated 100% container closure inspection, container closure validation studies, headspace microbial studies, in-process monitoring of oxygen during filling and for stability
studies, lyo cycle optimization, and lyo chamber moisture mapping.
LIGHTHOUSE offers a range of benchtop and in-line platforms with
patented laser sensor technology commercialized with the help of
funding from the Food and Drug Administration. In addition, headspace measurement services are delivered from laboratory facilities
in Amsterdam and Charlottesville, Virginia.
Lonza Cologne GmbH
Nattermannallee 1
50829 Kln
Germany
Tel: +49 221 99 19 91 90
Fax: +49 221 99 19 91 11
scientific.support.eu@lonza.com
www.lonza.com
Lonza Bioscience - Lonza is the trusted QC testing solution provider
for the pharmaceutical and medical device industries. Lonza transforms its practical knowledge and technical expertise to deliver a
portfolio of endotoxin, mycoplasma and microbial detection products, and paperless QC microbiology, software and services that
support the critical needs of regulated manufacturing environments.

14

#Microbiology2016

EXHIBITOR ABSTRACTS
Mar Cor
Sourethweg 11
6422 PC - Heerlen
The Netherlands
Tel: +31 45 5471441
Fax: +31 45 5429695
www.info.eu@mcpur.com
www.mcpur.com
Mar Cor is dedicated to provide innovative solutions through filtration (endotoxin removal filters), water and disinfection technologies.
We supply pharma grade Cold Sterilant and effective sporicides to
decontaminate surfaces in cleanrooms using manual procedures
(Actril Cold Sterilant) or automatic airborne decontamination systems for bigger production areas.
Merck Millipore
39 Route Industrielle de la Hardt
67120 Molsheim
France
Tel: +33 3 90 46 90 00
Fax: +33 3 90 46 91 90
laurence.chaumet@merckgroup.com
www.merckmillipore.com
As a division of Merck KGaA of Germany, Merck Millipore offers a
broad spectrum of proven tools and technologies, together with
performance solutions innovations, dedicated to helping our customers succeed in the research, development and production of biotechnology and pharmaceutical drug therapies. Comprised of three
business units Bioscience, Lab Solutions, and Process Solutions
Merck Millipore is a top tier supplier to the life science industry, and
serves as a strategic partner for scientists, engineers, and researchers. Headquartered in Billerica, Massachusetts, Merck Millipore has
around 10,000 employees in 67 countries motivated by the potential
of science for life through a portfolio of more than 40,000 products.

NSF Pharma Biotech Consulting

The Georgian House,
22/24 West End, Kirkbymoorside
York, YO62 6AF
United Kingdom
Tel: +44 1751 43 29 99
Fax: +44 1751 43 24 50
pharmamail@nsf.org
www.nsf.org
NSF Health Sciences Pharma Biotech Consulting is a major global
provider of pharmaceutical education, consultancy, auditing and
analytical testing. Our education programs include GMP courses,
QP Training, Sterile Manufacture, Human Error Prevention and IRCA
certified QMS auditor courses. NSF provides consultancy for GMP/
GDP compliance, quality management systems and regulatory enforcement action support. We conduct mock regulatory inspections,
supplier audits and certification. Our mission is to work in partnership with our clients to add value through Improving efficiency and
operational excellence through simplification of quality systems
and processes Helping companies adopt standards that are fit for
purpose through benchmarking Supporting companies in preparing for future challenges (business and regulatory) to stay ahead of
their competition Educating employees to improve business performance, robustness and flexibility Guiding companies to change
their culture!
PMT Partikel Messtechnik GmbH
Schafwsche 8
71296 Heimsheim
Germany
Tel: +49 7033 53 74 0
Fax: +49 7033 53 74 22
info@pmt.eu
www.pmt.eu
PMT offers an extensive range of particle counters for many applications whether you need to monitor in air, gases or liquids. Our range
of liquid particle counters are suitable for liquids from ultra-pure water to the most hazardous of chemicals. In addition to this range we
also offer particle identification products and viable particle counting (more information can be found under the microbiological monitoring section).

2016 PDA Europe

CMC Regulatory Compliance

for Biopharmaceuticals
22-23 September | Training Course | Rome | Italy

pda.org/EU/CMC2016

#Microbiology2016

15

STERIS
8 rue Abb de Rastignac
45380 La Chapelle Saint Mesmin
France
Tel: +33 6 19 32 04 28
Fax: +33 2 38 84 85 41
frederic_bar@steris.com
www.sterislifesciences.com

Veltek Associates Inc.

15 Lee Boulevard
19355 Malvern, PA
USA
Tel: +1 610 644 8335
Fax: +1 610 644 8334
vai@sterile.com
www,sterile.com

A global leader in infection prevention and contamination control.

STERIS has been providing leading Science and Solutions to the
Life Sciences industry for more than 100 years. Our participation
and reach in this field gives us a deep understanding of the high
standards and important mission which challenge our Customers.
Throughout our history, we have advanced the Science of infection
control, cleaning and sterilization by delivering new technologies
and Services which solve problems for our Customers. Our advanced portfolio of Formulated Chemistries and Capital Equipment
combined with our global team of respected industry professionals allow us to tackle difficult problems, find Solutions and provide
world class Service.

Veltek Associates, Inc. is a single source supplier for all of your contamination control needs. VAI manufactures a broad line of sterile
disinfectants, sporicides, cleaners and detergents in a variety of sizes. In addition to multiple sizes, these products are available in saturated wipe packs. Veltek Associates, Inc.s capabilities also include
viable monitoring equipment. This product line consists of portable
devices, compressed air/gas sampling and single unit multi location
systems with an assortment of capabilities. Cleaning devices, laboratory services, cleanroom garments and consulting services are all
part of the contamination control solutions VAI has to offer for every
compliance challenge.

TSI GmbH
Neukllner Str. 4
52068 Aachen
Germany
Tel: +49 241 52 30 30
Fax: +49 241 52 30 34 9
tsi.emea@tsi.com
www.tsi.com

An international leader in measurement technology for over 50

years, TSI Incorporated (www.tsi.com) designs and manufactures
precision instruments used for contamination control, respirator
fit testing, exposure monitoring, indoor air quality, ventilation testing, aerosol research instruments, and other key parameters in the
environment. TSI is presenting BIOTRAK, a 28.3LPM real time airborne viable and non-viable ISO 21501-4 compliant particle counter,
all particles analyzed can be collected for identification. Used as a
standalone instrument or integrated into the TSI FMS monitoring
software, BIOTRAK instantaneously detects airborne contamination and determines particle viability like no other instrument on the
market today.

2016 PDA Europe

Pharmaceutical
Freeze Drying
Technology
27-28 September 2016
Strasbourg | France

16

#Microbiology2016

The Parenteral Drug Association presents:

2016 PDA Europe

9th Workshop on Monoclonal Antibodies

20-21 September | Conference, Exhibition | 22-23 September | Education Program

Register by
20 August 2016
and SAVE!

pda.org/EU/MAB2016

20-21 September 2016

Rome | Italy

#Microbiology2016

17

The Parenteral Drug Association presents...

PDA Education
Program
22 February 2016
Pharmaceutical Water Systems
Pre-Conference Workshop
25-26 February 2016
Charting and Trending of
Environmental Monitoring Data
Two-Day Training Course
25-26 February 2016
Rapid Microbiological Methods
Two-Day Training Course
25-26 February 2016
Control, Validation and Monitoring
of Biofilms in Water Systems
Two-Day Training Course

18

#Microbiology2016

TWO-DAY TRAINING COURSE

Charting and Trending of

Environmental Monitoring Data

Please
Bring
Your Laptop Working on
Practical
Examples

From microbial counts to recovery rates in controlled rooms

Overview
This basic-level practical course will first present the methodology of microbial Environmental Monitoring (EM)
data analysis of samples of air (active and passive sampling) and of surfaces (contact plates) by both the statistical
distribution-based and the empirical distribution-free approaches and will help you address the following topics:
How to organize and present this abundant data in a meaningful way
To understand how distribution-based and distribution-free control limits are set
How to build informative and useful Control Charts with this data, using the software program Minitab17
How to demonstrate that the environmental microbial monitoring process behaves predictably and is under
a state of control
To detect a trend in the environmental microbial monitoring process
How to calculate the Contamination Recovery Rate suggested by the recent USP Chapter <1116> and how to
plot them with Excel
Case studies of microbial counts generated in facilities of sterile product manufacturing will be evaluated in view
of detecting a trend, a process average shift and/or evaluating the behavior of the environmental microbial monitoring process. To this purpose, each participant should, a few days before the course, download a 30 day free-trial
Minitab17 on a laptop in order to solve exercises and generate control charts.
Who Should Attend:
Microbiologists
Environmental Monitoring personnel
Quality Assurance
Regulatory Affairs personnel
Production Managers
QC Managers
Senior Management
Personnel involved in the preparation of the Annual Product Review
Learning Objectives:
Understand the fundamentals of Statistical Process Control for handling environmental monitoring data and
setting control limits
Provide Statistical Process Control tools to draw control charts and evaluate the behavior of microbial environmental monitoring processes of case studies
Present methods for implementing the new USP <1116> based on contamination recovery rates

Raphael Bar, PhD, BR Consulting

Raphael (Raphy) Bar is presently a pharmaceutical consultant for the Pharma and bio-Pharma industries. He
is consulting various companies and provides development and analytical support to investigational, generic,
new drugs as well as combination device-drug products. After a postdoc in biochemical engineering at UVA
(Va, USA), he joined the Hebrew University as a Lecturer in the Biotechnology program. He then joined the
pharmaceutical industry to manage analytical R&D and QC laboratories. For the last 10 years, Raphael has been
providing training courses to the pharma industry on analytical method development and validation, GMP-related issues and
statistical evaluation of laboratory data and environmental monitoring data. After serving as the Chapter President, Raphael is
currently a board member of Israel PDA chapter. Last but not least, he has been a member of the scientific advisory board of
global PDA (USA) during the years 2009 2015.

#Microbiology2016

19

CHARTING AND TRENDING OF ENVIRONMENTAL MONITORING DATA

11 Feb 2016

Thursday, 25 February 2016

20

9:00 18:00

9:00

Welcome

9:15

1. Introduction
QbD and trending
Overview of current regulations: microbial Action Limits in the classified
environments (FDA, EU, WHO and PDA TR 13)
New paradigm of Contamination Recovery Rates in aseptic environments
(USP chapter <1116>)
Run Chart vs. Shewhart Control Charts
Variables versus attributes charts

10:30

Coffee Break

11:00

2. Variability of Data
Standard deviation of a sample and of population
Histogram
Standard deviations of the mean
Range
Relation between standard deviation and Range
Short-term variation versus global variation
Separating the signal from noise
Common cause variation vs. Special Cause (Assignable) variation

12:30

Lunch Break

13:30

3. Control Charts of Grouped Data

Plotting Run chart and control chart (Process Behavior Chart)
Control charts of grouped data versus of individual data
Computation of three-sigma Control limits
Control charts of average, range and standard deviation
Should the plotted microbial counts obey a Normal or Poisson distribution?
Should the plotted data be transformed?
Exercises: Calculation with Excel of control limits and drawing charts of microbial counts

15:00

Coffee Break

15:30

4. Brief Acquaintance with Minitab 17

Basic structure of Minitab software
Drawing a Control Chart

16:00

5. Control Charts of Individual Data

Moving range (mR)
Control charts of individual data (XmR)
Calculation of control limits
Transformation of data
Exercises: Building with Minitab control charts of microbial counts from passive and
active air sampling

18:00

End of Day 1

#Microbiology2016

CHARTING AND TRENDING OF ENVIRONMENTAL MONITORING DATA

Friday, 26 February 2016

9:00 16:30

9:00

6.Distribution-Based Approach
Poisson distribution
Normal distribution
Understanding the statistical approach for setting control limits
Control limits based on a given distribution (Negative-Binomial, Weibull, Gamma)
Disadvantages of the distribution-based approach
Examples of control limits based on Poisson, Normal, Negative-Binomial, Weibull for Grade C

10:30

Coffee Break

11:00

7. Distribution-free Approach
Non-parametric percentile as control limit
Tolerance intervals limits
Shewhart approach for setting control limits
Laneys charts (hybrid control charts)
Contaminations rates
Contamination recovery rates (USP <1116>)
Exercises of percentile determination, plotting of Laneys charts,
Calculations of contamination recovery rates per USP <1116>

12:30

Lunch Break

13:30

8. General Approach to Microbial Monitoring

Overall strategy for microbial monitoring
Proposed decision scheme for EM High Counts
Proposed decision scheme for EM Low Counts
Proposed decision scheme for Rare Contamination Events
Plotting Contamination recovery rates
Plotting Alert and Action excursions rates
Exercises: Determining Alert Limits with the methods of percentile and confidence intervals;
Control charts of microbial counts of active air samples in area Grade B and contact plates in
area Grade C; plotting Contamination Recovery rates

15:00

Coffee Break

15:30

9. Strategy for Detecting a Trend and for Continuous Improvement

Initial phase of control charting
Strategy of control charting
EM process stability versus capability
Nelson rules
Trending and continued process verification
Example of detecting a shift in microbial counts

16:30

End of Training Course

#Microbiology2016

21

TWO-DAY TRAINING COURSE

Rapid Microbiological Methods

Overview
This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations,
financial justification models and implementation plans. Taught by one of the industrys global leaders in
rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.
Who Should Attend:
Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation,
Regulatory Affairs, Research and Development, Validation, QP
Level of Expertise: Senior Management, Scientists/Technicians
Job Function: Supervisor, Researcher, Analyst, Operative Personnel
Learning Objectives:
Discuss the benefits of alternative and RMM technologies as compared with classical microbiological
methods
Describe the scientific basis for a variety of technologies that may be qualified as alternative methods
to classical microbiology procedures; explore case studies and actual workflows for dozens of commercially-available technologies
Explain the regulatory environment, guidance, policies and expectations for validation, submissions
and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change
acceptance levels
Develop business plans and return on investment justifications, follow an actual case study in significant cost savings and cost avoidances by implementing a RMM for environmental monitoring
Apply industry best practices for validating these new technologies in order to demonstrate that the
methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand
the differences between PDA TR 33, the new USP 1223 chapter and the proposed Ph. Eur. Chapter 5.1.6

Michael J. Miller, PhD, President, Microbiology Consultants, LLC

Michael J. Miller, PhD, is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid
microbiological methods.

22

#Microbiology2016

TRAINING COURSE AGENDA

11 Feb 2016

Thursday, 25 February 2016

9:00 18:00

9:00

Welcome

9:15

Introduction to RMMs, Applications, Implementation Strategies, Opportunities

Growth-based RMMs; Scientific Principles, Applications and Case Studies

10:30

Coffee Break

11:00

Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO

12:30

Lunch Break

13:30

Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies

Viability-based RMMs; Scientific Principles, Applications and Case Studies

15:30

Coffee Break

16:00

Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies

Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles,
Applications and Case Studies

18:00

End of Day 1

Friday, 26 February 2016

9:00 16:30

9:00

Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies

10:30

Coffee Break

11:00

MEM-based RMMs; The Future of Alternative Technologies

Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and
PQ Strategies, Validation Acceptance Criteria, Use of Statistics

12:30

Lunch Break

13:30

Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33,

the New USP 1223 and the Proposed Ph. Eur. 5.1.6
A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI)
Calculations

15:00

Coffee Break

15:30

References, On-line Resources and Final Remarks

16:30

End of Training Course

#Microbiology2016

23

TWO-DAY TRAINING COURSE

Control, Validation and

Monitoring of Biofilms in
Water Systems
Overview
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems.
The chemical purification processes are well understood and relatively easily achieved. However, the microbiological purity of the finished water and the impact and control of biofilm on the purification train
is NOT widely understood, sometimes even by the sites microbiologists or QA, let alone by the engineers
and other utilities maintenance personnel tasked with maintaining microbial control.
In order to understand the microbiology of a water system, one has to understand biofilms since that is
the mode of microbial growth in a water system. There is much hype and fear about water systems biofilms by users and regulators alike who do not understand how they grow, how to effectively control that
growth, or even how to monitor their presence. This course will help you understand how microorganisms
respond to our efforts (or lack of effort) to control their numbers and even to how we try to count them.
This course is designed to provide a microbiology-focused education in language understandable by all
personnel, microbiologist and non-microbiologist alike who have any involvement with water systems.
The instructor can provide the necessary background needed to understand this very important subject
matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, and investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often do not work and can cause very costly system downtime or even
product recalls.

Teri C. Soli, PhD, Soli Pharma Solutions, Inc.

T.C. Soli has over 35 years of combined pharmaceutical experience with operating companies and as a consultant. He is President of Soli Pharma Solutions, Inc. Dr. Solis career-long
experience with water systems and product and process contamination troubleshooting,
coupled with USP, ISPE, and PDA committee involvements, afford him this practical knowledge and troubleshooting skill.

24

#Microbiology2016

TRAINING COURSE AGENDA

11 Feb 2016

Thursday, 25 February 2016

9:00 - 18:00

9:00

Module 0 Introductions

9:15

Module 1 Basics of Water System Biofilm Control by Design & Operation

11:00

Coffee Break

11:15

Module 2 Successful Water System Sanitization

13:00

Lunch Break

14:00

Module 3 Water System Validation by Logic Instead of Tradition

15:30

Coffee Break

15:45

Module 4 Understanding and Controlling Endotoxins

16:15

Module 5 Harmonizing vs Optimizing Water Microbial Testing for System QC

17:00

General Q&A (On and Off-Topic)

18:00

End of Day 1

Friday, 26 February 2016

9:00 - 17:00

9:00

Module 6 Microbial Enumeration Issues with High Purity Water Systems

10:30

Module 7 Reducing Water Microbial Excursions & Improving Investigations

11:30

Coffee Break

11:45

Module 8A Water System Investigation "How-To's" and Example Case Studies

12:30

Lunch Break

13:30

Module 8B Water System Investigation "How-To's" and Example Case Studies

14:30

Module 9 Leadership in Manufacturing Contamination Control: The Microbiology Lab

15:30

Coffee Break

15:45

Module 10 What USP Does & Doesnt Say about PW, WFI, Pure Steam & Micro Issues

16:30

General Q&A (On and Off-Topic)

17:00

End of Training Course

#Microbiology2016

25

Registration Form Page 1

Your Contact Person is

Antje Petzholdt at PDA Europe
petzholdt@pda.org
This PDF-file provides an automatic
fill-in function. Your signature,
however, is needed in writing.

PDA Europe Conference, Exhibition, Workshop, Training Courses

Pharmaceutical Microbiology
23-24 February 2016 | Berlin | Germany

Your registration is only complete upon filling in and submitting both pages of this form.

Registration

No PDA membership included

EARLY BIRD DISCOUNT

Book by 23 January to receive 150 off the conference fee only

All fees given in Euro, excluding VAT (7 %)

22 February

Half-Day Pre-conference Workshop

Workshop Fee

netto

PDA Member/Nonmember

400

Regulatory/Academic

200

Conference Fee

netto

PDA Member

1495

Nonmember

1745

Regulatory/Academic

750

Training Course Fee

netto

All Participants

1395

Two-Day Training Course

Training Course Fee

netto

Charting and Trending of Environmental Monitoring Data

All Participants

Pharmaceutical Water Systems

23-24 February

Conference only

Pharmaceutical Microbiology

25-26 February

Two-Day Training Course

Rapid Microbiological Methods

25-26 February

25-26 February

Two-Day Training Course

Control, Validation and Monitoring of Biofilms in Water Systems

1395

Training Course Fee

netto

All Participants

1395

The fee includes course documentation as well as mid-session refreshments and lunch.
Excellent networking opportunities with snacks and drinks will be given.
The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.

Group Registration Discount Register 5 colleagues for the conference at the same time and receive the
5th registration free. For more information on group discounts please contact Antje Petzholdt at petzholdt@
pda.org. Other discounts cannot be applied.

Discount for Exhibiting Companies

Join PDA and receive the

Membership Rate Today!
Please go to:
www.pda.org/membership

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 995 Euro
per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

26

#Microbiology2016

Registration Form Page 2

Your Contact Person is

Antje Petzholdt at PDA Europe
petzholdt@pda.org

PDA Europe Conference, Exhibition, Workshop, Training Courses

This PDF-file provides an automatic

fill-in function. Your signature,
however, is needed in writing.

Pharmaceutical Microbiology
23-24 February 2016 | Berlin | Germany

4 WAYS
TO REGISTER

1
2
3
4

ONLINE: https://europe.pda.org/Microbiology2016
FAX: +49 30 4365508-66
EMAIL: petzholdt@pda.org
MAIL: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Your Contact Information

If this form is an update to a previously submitted form, please check here.

Mr.

Ms.

Dr.

I want to become a PDA Member.

Please send me a subsription form

Nonmember
PDA Member

Name (Last, First, MI) *

ID Number

Job Title *
Company*

Department

Mailing Address
City

Postal Code

Country

Email

Business Phone

Fax

Substituting for
(Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the member ship fee.)

* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

Information about Visa Matters

All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event
at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.

All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)

Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU
(together with their registration).

Payment Options
By Bank Transfer

Beneficiary: PDA Europe gGmbH

IBAN: DE73 1007 0024 0922 8735 00
BIC (SWIFT-Code): DEUTDEDBBER
Bank Address:
Deutsche Bank, Welfenallee 3-7,
D-13465 Berlin, Germany

Your Company
VAT I.D.:

By Credit Card (one week prior to event)

American Express

MasterCard

Purchase Order
VISA

Purchase Order Number

For your credit card information safety:

Please send your details by fax only.
Billing Address:

Same as contact information address above.

If not, please send your billing address to: petzholdt@pda.org
PDA Europe VAT I.D.: DE254459362

This number starts by your country code with two characters

(example: PDA Europes country code starts with: DE | followed by the number)

Your registration is only complete upon filling in and

submitting both pages of this form.

Date

Mandatory Signature

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded
once PDA Europe has sent a written invoice by mail to you. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment
must be received or guaranteed by Purchase Order or credit card details on 1st day of event, at the very latest. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site
at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a
charge of 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 23 January 2016, you will receive a full refund minus a 150 excl. VAT handling fee. After
that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference
materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event.
If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact
PDA at info-europe@pda.org or fax to+49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the
recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

#Microbiology2016

27

Helpful Hints When Registering for PDA Europe Events

MAKING IT EASIER FOR BOTH OF US

1

Please include your member ID number on registration form if available/known

If uncertain about your member ID number and/or your membership status, call or email Ms. Antje Petzholdt.
+49 30 4365508-10

petzholdt@pda.org

Do not send money in advance

Please wait until we send our invoice to you.

It is helpful to reference our invoice number in your bank transfer details.

Complete and sign the event registration form

Please note the registration and cancellation policies at the bottom of the form.

Purchase Orders

Registration cannot be completed by sending Purchase Order alone. A Purchase Order is only accepted if a
complete registration form is enclosed or follows very soon.

Please state VAT ID number if European-based Company

This number starts by your country code

(example: PDA Europes VAT ID number = DE254459362)

Please state the correct billing address on the registration form

This is particularly important if billing address and site address are different. Contact your accounting department for correct address and company name. There could be special requirements for accounting. Changes in
the billing address (if induced by participating company) will be charged 25,- if imposed 3 weeks prior to the
start of the event.

Confirmation of your registration

Credit card charges are confirmed immediately if successfully approved.

Bank transfers are confirmed upon receipt of full payment.

Refund/Credit Notes

Refunds to credit card can be done immediately if payment had been done by credit card and details are
available. Refunds to bank accounts can be done if payment had been done by bank transfer and the following
details are provided:
a) Name of your bank
b) IBAN number c) Swift/BIC code

Substitutions

If a participant is unable to attend, substitutions are welcome at any time. Changes are free of charge until
3 weeks prior to the start of the event. After this date, there will be a charge of 50 per name change.

10

For assistance contact: Antje Petzholdt, PDA Europe

Tel: +49 30 4365508-10

Email: petzholdt@pda.org

T H A N K Y O U F O R Y O U R C O O P E R A T I O N!
28

#Microbiology2016

INFORMATION
Scientific Program Planning Committee
Di Morris, GSK
Paul Newby, GSK
Sandra Gay, bioMrieux
Heike Merget-Millitzer, Janssen Cilag
Michael Miller, Microbiology Consultants
Johannes Reich, Hyglos
Olivier Rocher, GSK Vaccines
Christian Scheuermann, Charles River
Sylvia Becker, PDA Europe
Falk Klar, PDA Europe
Contacts
For additional conference information please contact:
Conference Inquiries
Melanie Decker
Director Events & Exhibitions
decker@pda.org
Conference Program Inquiries
Sylvia Becker
Manager Programs & Events
becker@pda.org
Registration Customer Care
Antje Petzholdt
Membership Management
petzhold@pda.org
Education Program Inquiries
Elke von Laufenberg
Manager Training & Education
laufenberg@pda.org
Exhibition/Sponsorship Inquiries
Creixell Espilla-Gilart
Manager Exhibition & Sponsorship
espilla@pda.org
To Exhibit:
Exhibition and Sponsorship Opportunities are available. PDA
meetings and conferences are a great opportunity for your
company to gain on-site exposure in front of highly-qualified,
upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your companys
products or services become a valuable tool or resource for our
attendees.

General Address
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: +49 30 4365508-0
Fax: +49 30 4365508-66
Venue
Hotel Palace Berlin
Budapester Str. 45
10787 Berlin, Germany
Tel.: +49 30 2502-0
Fax: +49 30 2502-1119
hotel@palace.de
http://www.palace.de/en/hotelen.html
Special Rates
PDA Europe has reserved a limited number of rooms , please
inquire for availability of the PDA Group Rate.
Single Room 129 per night
Double Room 149 per night
including breakfast, VAT and Service Charge City tax applies.
Directions:

HOTEL PALACE
BERLIN
Google For directions click on the picture, scan the QR-code or go to

https://goo.gl/maps/mT1ZXz1vTdD2

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Partner Airlines offer a comprehensive global
route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and
their travel companions. To make a reservation, please click on
www.lufthansa.com/event-booking_en and enter the access code
DEZZYSX in the "Access to Your Special Lufthansa Offer" area. This
will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if
another promotional fare is available.
NOTE: Pop-ups must be enabled otherwise the booking platform
window will not open.
These promotional fares are also available through your IATA / ARC
travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the
access code as a reference.

#Microbiology2016

29

2016 PDA EUROPE ACTIVITIES & EVENTS

22 February
23-24 February
25-26 February
25-26 February
25-26 February

Pharmaceutical Water Systems

Pharmaceutical Microbiology | Conference
Rapid Microbiological Methods
Charting and Trending of Environmental Monitoring Data
Control, Validation and Monitoring of Biofilms in Water Systems

WS

1 March
1 March
2-3 March
4 March

Interest Group Meeting Visual Inspection

Interest Group Meeting Freeze Drying
An Introduction to Visual-Inspection: A Hands-on Course
Particle Identification in Parenterals

IG
IG
WS
WS

11 April
12-13 April
14 April
14-15 April
14-15 April
14-15 April
14-15 April

Interest Group Meeting Pre-filled Syringes

Parenteral Packaging | Conference
Container Closure Development
Extractables and Leachables
Container Closure Integrity: Regulations, Test Methods, Application
Good Glass Handling Practices in Parenteral Packaging
Drug Delivery Combination Products

IG

19-20 April

Data Integrity

WS

London, UK

25-29 April

Praxis der Pharmazeutischen Gefriertrocknung

TC

Osterode, Germany

2-3 May

Critical Demands on Modern Pharmaceutical Packaging

WS

Bern, Switzerland

31 May - 1 June

Annex 1

WS

Berlin, Germany

6 June
7-8 June
9 June

Viral Safety of ATMPs | Conference

Advanced Therapy Medicinal Products | Conference
Practical Application of GMP for Development of ATMPs

TC

28-29 June
30 June
30 June
30 June - 1 July
30 June - 1 July

1st PDA Europe Annual Meeting

Test Methods for Pre-filled Syringe Systems
Cleaning and Disinfection
Root Cause Investigation
Development of a Pre-filled Syringe

TC
TC
TC
WS

20-21 September
22 September
22-23 September
22-23 September
22-23 September
22-23 September

9 th Workshop on Monoclonal Antibodies

Elastomers
CMC Regulatory Compliance for Biopharmaceuticals
Extractables and Leachables
Introduction to Aseptic Processes Principles
Statistics of Production Monitoring and Capability

TC
TC
TC
TC
TC

27-28 September
29 September
29-30 September

Pharmaceutical Freeze Drying Technology | Conference

Application of a Risk-Based Approach to Freeze-Drying Processes
Development of a Freeze Drying Process

TC
WS

Strasbourg, France

5-6 October

Annex 1

WS

Dublin, Ireland

10 October
11-12 October
13-14 October

Interest Group Meeting Pharmaceutical Cold Chain

Pharmaceutical Cold & Supply Chain Logistics
Good Cold Chain Practices

IG

24 October
25-26 October
27-28 October

Particle Identification in Parenterals

Visual Inspection Forum
An Introduction to Visual Inspection: A Hands-on Course

TC

8-9 November

Data Integrity

WS

14 November
15-16 November
17 November
17-18 November

Risk-based Approach for Prevention and Management of Drug Shortages

Outsourcing & Contract Manufacturing | Conference
Quality by Design for Biopharmaceuticals
Root Cause Investigation

TC

Subject to change

For latest info: europe.pda.org

General Information
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: +49 30 4365508-0
Fax: +49 30 4365508-66

Conference Information
Melanie Decker
Director Events & Exhibitions
Tel: + 49 30 4365508-19
decker@pda.org

Training Course Information

Elke von Laufenberg
Manager Training & Education
Tel: + 49 30 4365508-21
laufenberg@pda.org

TC
TC
TC

TC
TC
WS
WS
WS

WS

TC

TC
TC

Berlin, Germany

Berlin, Germany

Venice, Italy

Berlin, Germany

Berlin, Germany

Rome, Italy

Amsterdam,
The Netherlands

Berlin, Germany
Berlin, Germany

Barcelona, Spain

Shortlist 11 Feb 2016

Legend
IG Interest Group Meeting
TC Training Course
WS Workshop
europe.pda.org