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
Regulatory Requirements For Medical Device Recalls
Health Hazard Evaluation
Recall Letter, Envelope, and Return Response
Recall Effectiveness Check: Letter, Questionnaire, and Response
Recall Status Reports
Terminating a Recall
Mandatory Device Recall
Corrections And Removals
Enforcements: Case Studies
PASS-IT Recommendations: Best Practices
Who will Benefit:
Complaint And Risk Management Personnel
Other Interested Parties