Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
WebcastFaculty
OVERVIEW
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data is organized by Compliance Global Inc and would be held on May 22, 2017.
Overview :
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. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings.
Why Should You Attend :
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance; your firm's CAPA system is useful and meaningful.
Areas Covered in this Webinar :
• Regulatory Requirements
• FDA QSR
• ISO 13485
• 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
Overview :
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. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings.
Why Should You Attend :
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance; your firm's CAPA system is useful and meaningful.
Areas Covered in this Webinar :
• Regulatory Requirements
• FDA QSR
• ISO 13485
• 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
SPECIALITIES
Risk Management and Medical Negligence
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