Overview: This webinar is intended to demonstrate how to adequately establish and maintain medical device complaint handling systems. All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products.
This webinar will discuss how to implement medical device complaint handling procedures, how to achieve compliance, and how to remain compliant. At the end of the webinar, you will get familiarized with the FDA-compliant system for handling all types of medical device complaints.
Why Should You Attend: FDA regulations require all medical device manufacturers to comply with the complaint requirements. This webinar will discuss how to adequately establish and maintain medical device complaint handling systems.
Areas Covered in the Session:
Applicable statutes and regulations for medical device complaint handling
What to do when complaints are received?
How to process complaints.
What processes need to be in place?
When to investigate complaints.
When to open a CAPA(s).
Investigation and documentation requirements
Relationship between complaints, MDR, and CAPA
Enforcement actions: numerous case studies
Who Will Benefit:
Complaint Handling Personnel
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation.
Live : $199.00
Corporate live : $399.00
Recorded : $249.00