Webinar on Conducting Successful Product Complaint Investigations
November 11, 2015 - Fremont CA USNetzealous - Compliance4All
support@compliance4all.com
Phone:+1-800-447-9407
Fax:302-288-6884
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, 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. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO. Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing. 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