Objectives of the Presentation:
- Gain knowledge of the complete Post-Market Surveillance system
- Understand how Post-Market Surveillance relates to other systems within the manufacturing process
- Know how to integrate all of the systems to make sound, proactive decisions
- Possess tools to implement resulting actions of post-market data
- Understand how investigations, CAPA, risk management, design controls and other processes are required for a good post-market surveillance strategy
Why Should you Attend:
The Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct post-market surveillance. The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative and not deceptive.
- Introduction to post-market surveillance
- Returned goods
- Complaint handling
- Product stability
- Annual product reviews
- Corrections & removals or recalls
- Post-market procedure
Proactive and reactive source of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products.
Kenneth F. Miles,
Miles Technologies Group
Dr. Kenneth F. Miles is a seasoned professional in Quality, Regulatory and Clinical affairs and development strategy for drugs, biologics, medical devices and combination products. He has worked in senior quality and regulatory roles in the medical products industry for more than 20 years. Dr. Miles has worked for a number of large and small pharmaceutical, biotech and medical device companies. He also interfaced with FDA at Local, District and Centre levels and has dealt with several foreign ministries to bring companies into compliance. He has set up regulatory and quality systems for countries around the world, including the Pacific Rim, Europe and South America. He is the senior member of the American Society for Quality, (Certified Quality Engineer) and member and Fellow of Regulatory Affairs Professional Society (Certified Regulatory Affairs). Dr. Kenneth F. Miles is the recipient of the GMP Institute Hall of Fame Award.