2012 - Complaint Handling and Management: From Receipt to Trending

Overview: 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.
The results of this 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. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. 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. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.
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:
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. The employees who will benefit include:
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
Consultants
Operations and Manufacturing
David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.
Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00
Phone: 800-447-9407
Fax: 302-288-6884
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