Complaint Handling 2018 - 3-Hour Virtual Seminar on 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:
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
Speaker Profile
David R. Dills, Global Regulatory Affairs & Compliance Consultant, President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customergenerated compliance events, and prepares for and conducts QS and regulatoryaudits. He is currently acting and interim President at NovaQual LLC.
Event link : http://www.compliance4all.com/control/w_product/~p...
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com