Implementing Medical Device Complaint Handling Systems - Webinar By GlobalCompliancePanel November 13, 2012

Overview: This webinar is intended to demonstrate how to implement 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 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 implement medical device complaint handling systems.

Areas Covered in the Session:
Overview and review of the applicable statutes and regulations
Definitions
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).
Contents of records of investigation.
Enforcement actions: numerous case studies
Lessons learned

Who Will Benefit:
CEOs
VPs
Compliance officers
Attorneys
Complaint handling personnel
Clinical affairs
Regulatory affairs
Quality assurance
R&D
CROs
Consultants
Contractors/subcontractors

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. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/UIhYS4