Event Date/Time: Sep 30, 2008
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and 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? Since the US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be "risk based", how can this be implemented under CAPA. Changing a company's CAPA system to a true risk-based closed-loop system results in a redistribution of scarce resources to activities that have a higher payoff in terms of reduced liability, both civil and regulatory, and improved product function and safety - resulting in a "bullet proof" CAPA system.
Areas Covered in the seminar:
* FDAâ€™s and EUâ€™s Emphasis.
* QSIT for a strategic, systems analysis of CAPA and high risk concerns.
* How to use your Risk Management Tools (per Q9 and ISO 14971)?
* CAPA â€“ a crucial series of risk-based lifecycle deliverables.
* Corrections and Risk.
* Corrective Action and Risk.
* Preventive Action and Risk.
* Closing the Loop.
* Incorporate external databases for a truly â€œbullet proofâ€ CAPA system.
* Management Review â€“ tying it all together; taking it to the next level.
Who will benefit:
* Senior Management.
* Project Leaders.
* Regulatory Affairs.
* Quality systems personnel / QAE.
* R&D and engineering staff.
* Personnel involved in Lean and Six Sigma Initiatives.
* New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach.
* CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.