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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
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/2aWYZbK
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