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.
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:
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/1ivKGsn
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