CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations 2011

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

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

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http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884