Best Practices for Medical Device Recalls

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Description:

In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain adequate procedures for medical device recalls, corrections and removals.

This webinar is intended to help device industry establish adequate procedures for medical device recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements.

This webinar will provide a great opportunity to adequately plan, develop and execute the relevant procedures in an effective, sustainable manner compliant with the recall requirements enforced by US FDA.

Areas to be Covered:

Laws And Regulations
Definitions
Regulatory Requirements For Medical Device Recalls
Voluntary Recalls
Health Hazard Evaluation
Recall Classification
Recall Strategy
Recall Letter, Envelope, and Return Response
Recall Effectiveness Check: Letter, Questionnaire, and Response
Recall Status Reports
Terminating a Recall
Public Notification
Mandatory Device Recall
Corrections And Removals
Recall Reporting
Documentation Requirements
Checklists
Enforcements: Case Studies
PASS-IT Recommendations: Best Practices

Who will Benefit:

CEOs
VPs
Clinical Affairs
Regulatory Affairs
Quality Professionals
R&D
Complaint And Risk Management Personnel
Consultants
Contractors/Subcontractors
Other Interested Parties

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance