This CAPA systems webinar will guide you through the role of Corrective and Preventive Actions (CAPA) systems will be discussed within the context of risk management practices.
The FDA’s Investigations Operations Manual (2006) notes: "How firms identify the causes of medical device recalls and corrective action activities is essential to the analysis of medical device failures and the determination of the effectiveness of the medical device GMP program."In the context of post-marketing surveillance, internal preparations for a recall need to be on your immediate list of concerns. Recalls can be very disruptive to a company, but preparation in advance can make a significant difference in minimizing this disruption. The FDA’s Investigations Operations Manual (2006) notes: "How firms identify the causes of medical device recalls and corrective action activities is essential to the analysis of medical device failures and the determination of the effectiveness of the medical device GMP program." The role of Corrective and Preventive Actions (CAPA) systems will be discussed within the context of risk management practices.
Areas Covered in the seminar:
- Why are CAPA systems important?
- What role do they have within risk management?
- How do CAPA programs play a role in potential or ongoing recalls
Who will benefit:
This presentation will provide an overview of Corrective and Preventive Actions (CAPA) systems and give a review of what FDA inspectors are looking for when they review CAPA systems. The focus will be on how to identify existing and potential problems. The employees who will benefit include:
- Engineering staff in design and manufacturing
- Health professionals who interface with physician or patient users
- QA managers and personnel
- Regulatory Affairs managers and personnel
Instructor Profile:
Marta L. Villarraga, Ph.D. is a Principal Engineer at Exponent, Inc, a scientific and engineering consulting firm. Dr. Villarraga concentrates her practice in failure analysis of medical devices in the areas of product liability, intellectual property, regulatory compliance, quality control and manufacturing compliance. She has assisted companies with root cause analyses prior to a recall or as part of the investigation following a recall being announced. Dr. Villarraga is also a reviewer for various scientific journals. She has also published a number of scientific articles and frequently presents at national conferences. She recently contributed to various chapters in the book "Bringing your Medical Device to Market," including one on medical device recalls. She also holds adjunct faculty appointments at various local and regional universities where she often lectures.
