Corrective And Preventive Action in FDA Regulated Industry

Overview:

This webinar will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data.

Detail will be provided for each specific element of a CAPA program in the proper sequence, beginning with the initial detection and documentation of a nonconformance, continuing on with investigation to determine root cause, corrective/preventive action, and assuring that data confirm the corrective action has been effective in addressing the root cause.

Why you should Attend:

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.

Areas Covered in the Session:

• Regulatory Requirements
  • FDA QSR
  • ISO 13485
• Procedural Contents
• Definitions
• Elements of a cross-procedural CAPA program
• Detection of Nonconformance
• Root Cause (NOT proximal cause!) Investigation
• Corrective Action
• Determination
• Performance
• Implementation
• Effectiveness of Corrective Action

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• QA management
• CAPA coordinator
• Regulatory Affairs management
• Executive management
• Consultants
• Quality System Auditors