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Conducting Successful Product Complaint Investigations

Conducting Successful Product Complaint Investigations

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Areas Covered in the Session:
Understand how and why CAPA is tied in to product complaint investigations
Examples of tools currently being used to conduct investigations
How far and in-depth do you go with your investigations
What are current FDA "hot" buttons and trends
Benchmarks and best practices for investigations
How to become a "good" investigator and the emphasis on closed-loop investigations
Why risk-based approaches are vital to the decision-making process
How to improve and bullet-proof your product complaint management system with investigations

Who Will Benefit:
All levels of Management for all departments and those who desire a better understanding
QA/QC/Compliance/Regulatory Affairs
Marketing & Sales & Customer Service
Engineering/Technical Services
Operations and Manufacturing

Speaker Profile:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.

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