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Webinar on Conducting Successful Product Complaint Investigations

3/18/2014 10:00 AM - 11:00 AM

Overview:

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. 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, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1ahBN0t

Learn More: Webinar on Conducting Successful Product Complaint Investigations

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