Risk-Based CAPA Systems

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.

Areas Covered in the seminar:

• FDA's and EU'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 – a crucial series of risk-based lifecycle deliverables
• Corrections and Risk
• Corrective Action and Risk
• Preventive Action and Risk
• Closing the Loop
• Management Review – tying it all together; taking it to the next level

Who Will Benefit:

• Senior management, project leaders, internal / external consultants
• 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

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association), and publishs a newletter. He is a graduate of UCLA.

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