Overview:

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, nonconformance, and OOS failure investigations, and hazard analysis / risk management and mitigation
activities, the basic foundation of a viable CAPA system.
It is required in resolving verification and validation issues including data outliers that frequently but
are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective
and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation
and root cause analysis is a major element of cGMP compliance. If inadequately performed it is also a
key source of regulatory problems. How can companies allocate scarce resources to those activities
that have the greatest impact to product quality / safety, minimize resources on minor issues, and still
satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple
yet powerful tools? Use the templates, tools and methodology presented in this webinar to facilitate a
closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.
Why you should attend: Expectations for meaningful CAPA, supported by results-driven Failure
Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are
growing among regulatory agencies world-wide. EU's ISO 14971 (Device Risk Management) and the
FDA's QSIT (devices) and ICH Q9 (drugs), underscore this increased emphasis. A valid closed-loop
CAPA system requires defined failure investigation including systemic root cause analysis for true
problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and
repeatable failure investigation and root cause analysis is still not the industry norm.
The billions of dollars spent by industry annually on quality / GMP are not providing the product safety
or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper
up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA,
Validation and Quality Management Systems / cGMP planning, implementation and execution.
Areas Covered in the Session:

Regulatory "Hot Buttons"

The 4 Basic Steps to Problem Solving
A Suggested Investigation Template
ID / Document the Problem - CAPA, et al
Failure Investigation / Analysis Methodology - And One Possible Template
Use the 7 Tools to Find the Solution(s)
Monitor for Effectiveness
Lock In the Change - Close the Loop
Take It to the Next Level

Who Will Benefit:

Senior management in Drugs, Devices, Biologics, Dietary Supplements

QA
RA
R&D
Engineering
Production
Operations
Consultants; others tasked with product, process, CAPA resolution, failure investigation
responsibilities

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