This Medical device recall training will provide an overview on how to establish proactive practices to determine if, when you launch your medical device, you are also recall ready, explore the impact of managing the decision-making process of recall
Recalls can be very disruptive to a company, but preparation in advance can make a significant difference in minimizing this disruption. Well-managed recalls are not usually "an accident," but rather the result of extensive preparation ahead of time and assembling a "recall team" with all the right capabilities and experience. Establishing and implementing adequate risk management practices for a recall is imperative given that one can happen at any time during the life cycle of a marketed product. This presentation will provide an overview on how to establish proactive practices to determine if, when you launch your medical device, you are also "recall ready," and will explore the impact of managing the decision-making process of a recall if you ever have to face one.
Areas Covered in the seminar:
- What is a medical device recall? Review of classifcation
- How many class I recalls have occurred over the last 3 years
- Types of reasons for class I recalls over the last 3 years
- Conducting the recall: what is FDA looking for?
- The importance of a health hazard evaluation
- Evaluating and terminating a recall
- Preparing for a recall
- The role of risk management in being ready for a recall
Who will benefit:
This webinar will provide insight on medical device recalls, why they have happened and how to have a good plan in place in the event one were to happen in your firm. Companies who will benefit are from the medical device and combination product fields. The employees who will benefit include:
- QA managers and personnel
- Regulatory Affairs managers and personnel
- Consultants
- Engineering staff (design and manufacturing)
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.
