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Medical Device 2020 - Training on Managing Your Complaints and Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection



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Topics/Call fo Papers

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
Firms MDR reporting and FDA's handling of reports
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
Minimize your risk of regulatory enforcement actions
Session 1
Complaint Handling and FDA Expectations (90 mins)
Break (15 mins)
Session 2
Continuation Complaint Handling and FDA Expectations (30 mins)
Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries.

Last modified: 2020-09-19 00:24:09