Device Recalls & Vigilance - When to Report Complaints – Part 803 and Part 806

This Device recall & reporting webinar will highlight pitfalls in compliant handling and reporting. It will give a better clarity on regulatory process and terms by reviewing the FDA regulations governing recalls and reporting.

Why Should You Attend:

FDA has explicit complaint handling requirements and procedures. However due to inadequate compliant handling system/process many medical device firms face regulatory issues in both the European Union & the USA. Poor or inadequate compliant handling can be quite expensive resulting in poor customer relations, loss of sales. On top of that failure to report problems to regulatory agencies promptly results in costly regulatory action .

Areas covered in this webinar:

• 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:

This Webinar will explain the regulatory process and in understandable terms. Employees who wish to gain a better understanding include:

• Quality & Regulatory Professionals
• Manufacturing & Design Engineers
• Marketing Product Managers
  • Senior Management
  • Customer Support Personnel
  • Agents and Distributors