This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
FDA has explicit complaint handling requirements and poor complaint and reporting procedures often resulting in costly recalls and warning letters.
FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
Why Should You Attend:
All medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. Many medical device firms face regulatory issues as a result of inadequate complaint handling.FDA has explicit complaint handling requirements and poor complaint and reporting procedures often resulting in costly recalls and warning letters.
FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
Areas Covered in the Webinar:
- FDA's Complaint Definition 820.3 (b)
- Complaint Documentation
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections and Removals
- Warning Letters and Other FDA Remedies
- Complaint Handling Pitfalls
Who Will Benefit:
- Quality and Regulatory Professionals
- Manufacturing and Design Engineers
- Marketing Product Managers
- Documentation
Course Provider
John Chapman,
