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Medical Device Complaints, MDR’s and Recalls
Tuesday, May 14, 2013 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
This webinar 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.
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 & reporting procedures often result 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 Seminar:
- FDA's Complaint Definition 820.3 (b)
- Complaint Documentation
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections & Removals
- Warning letters and other FDA Remedies
- Complaint Handling Pitfalls
Who Will Benefit:
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Web seminar will explain the regulatory process and in understandable terms. Some employees who wish to gain a better understanding include:
- Quality & Regulatory Professionals
- Manufacturing & Design Engineers
- Marketing Product Managers
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.