In this Medical device recall training learn how to interface with FDA in regards to anticipated recalls, the communication, the response, how to prepare the public information.
Why Should You Attend:
In the recent past the US FDA has been criticized for its perceived failures in protecting the public from unsafe products. The widely publicized contaminated heparin use in medical products and drug failures such as Vioxxl have tarnished the image of FDA in its efforts to protect the public health. In response a new Commissioner was appointed with extensive experience in public health. She has rapidly changed FDA's response patterns to serious events.
The new FDA is working rapidly to improve its image with the public and with Congress in response to its perceived shortcomings over the past 20 years. This presentation will discuss how industry should interface with FDA in regard to anticipated recalls. Additionally we will discuss the potential response to the public in the event of a recall. The primary focus should be on providing a safe product and in the event of a failure to provide correct and complete information to protect the public health.
Areas Covered in the Seminar:
- Recent product recall failures.
- Analyzing product risks.
- CAPA prioritization.
- Communicating with FDA.
- Deciding on the response.
- Preparing the public information.
- Notifying the customers.
Who Will Benefit:
- Medical Device managers
- CAPA Managers
- Quality Managers
- Regulatory Compliance Managers
- Product Management
- Public Relations personnel
- Marketing Management
Instructor Profile:
Edwin L. Bills, During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group.
Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
