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Subscribe NewsletterWebinar on CAPA Challenges
Product Id
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600196
Overview: CAPA, Corrective and Preventive Action, is a major element of cGMP compliance. Sadly, it is also a key source of regulatory problems.
What are the greatest CAPA challenges? 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? The US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be "risk based". Changing a company's CAPA system to a true risk-based closed-loop system can result in the proper use of scarce resources, directed to activities that have a higher payoff in reduced liability, both civil and regulatory, and improved product function and safety.
What are the greatest CAPA challenges? 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? The US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be "risk based". Changing a company's CAPA system to a true risk-based closed-loop system can result in the proper use of scarce resources, directed to activities that have a higher payoff in reduced liability, both civil and regulatory, and improved product function and safety.
Areas Covered in the Session:
- FDA's and EU's emphasis
- Major CAPA challenges
- 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
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.