Overview:

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

The results of this complaint handling software evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product.

Why Should You Attend:

A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action plan. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution.

Areas Covered in this Webinar:

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

Learning Objectives:

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 steps
How to improve and bullet-proof your product complaint management system with investigations

Who Will Benefit:

Management Team
QA/QC/Compliance/Regulatory Affairs Personnel
Marketing/Sales/Customer Service Professionals
Engineering/Technical Services Professionals
Consultants
Operations and Manufacturing Personnel

Speaker Profile:

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.

Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives

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