Live Webinar
on
Conducting Successful Product Complaint Investigations
Date & Time: Thursday, December 1, 2011
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: David R. Dills
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
David R. Dills Industry Regulatory & Compliance Consultant,
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations An effective complaint handling system is an extremely important part of any quality system.
Areas Covered in the Session: l
Understand how and why CAPA is tied in to product complaint
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investigations Examples of tools currently being used to conduct investigations
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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
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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. ...more
Who Will Benefit: The employees who will benefit include: Suggest a Topic l
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All levels of Management for all departments and those who desire a better understanding QA/QC/Compliance/Regulatory Affairs
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