Good Post-Market Surveillance

Duration: 60 Minutes
Post-Marketing Surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. The purpose of post-market surveillance is to protect individual health and public health through continued surveillance of products once they are placed on the market by reducing any risks. Such activities should ensure the manufacturer's obligations are fulfilled through ensuring they are aware of event which enables them to undertake and assessment of any risks and as appropriate any suggested steps to risk mitigation.
Post-Market surveillance
Instructor: Kenneth F. Miles
Product ID: 501998
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.

Areas Covered
  • Introduction to post-market surveillance
  • Returned goods
  • Complaint handling
  • Product stability
  • MDR
  • Vigilance
  • Annual product reviews
  • Corrections & removals or recalls
  • Post-market procedure
Who will Benefit
  • Regulatory Professionals
  • Quality Managers
  • Clinical Affairs Specialists
  • Complaint Handling Specialists
  • Design and Development Professionals
Topic Background
Proactive and reactive source of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products.
$375
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Instructor Profile:
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.


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