Conducting Successful Product Complaint Investigations

Event Details

Time: March 18, 2014 from 10am to 11am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/1ahBN0t
Phone: 8004479407
Event Type: webinar, pharma, medical, clinical, health
Organized By: John Robinson
Latest Activity: Feb 28, 2014

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Event Description

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.

Quick Contact:

GlobalCompliancePanel
USA Phone:800-447-9407
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1ahBN0t