Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Areas Covered in the Session:
Elements of a cross-procedural CAPA program
Applications of CAPA
CAPA Data, and best practices for its use
Application of risk management to CAPA program
Who Will Benefit:
Regulatory Affairs management
Quality System Auditors
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation.
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