Compliance4All, Online Event
2016-10-04
Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems.
Areas Covered in the Session: How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria How to facilitate a product complaint investigation as part of your CAPA program What is a closed-loop investigation…cradle to grave approach How to conduct an investigation using a well-written CAPA policy and procedure Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions
Who Will Benefit: This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include: All levels of Management for all departments and those who desire a better understanding or a "refresh" overview QA/QC/CAPA Coordinators/CAPA Specialists Regulatory Affairs and Compliance Engineering/Technical Services/Operations Consultants
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