Engaged. Knowledge. Application
WEBINAR Recording - CAPA: Implementing an Effective Program: Lessons From the Trenches
Instructor: Will McQuillen
Global Manager, Change Document and Records Management
Cordis, a Johnson & Johnson Company
➢PowerPoint Presentation (PDF)
➢Webinar recording
➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile
Webinar Content
• Definition of a CAPA
• Benefits of an effective CAPA program
• GMP requirements for CAPA systems: Written procedures, Systems to capture issues escalated to CAPA, Responsibilities for QA, operations, engineering and regulatory personnel, Assessment for observed nonconformities,Comprehensive investigations, Project plan development, Effective monitoring, Close-out documentation, System trending
• Documentation requirements for CAPA
• Current FDA expectations, inspection trends and example citations
• Practical aspects of managing the CAPA system during FDA inspections
Who Should Attend
This webinar is an ideal presentation for those individuals in your organization involved in the following functions:
• Managing the CAPA system
• Conducting investigations
• Quality assurance
• Quality control
• Quality systems
• Quality engineering
• Production
• Research & development
• Management involved in any aspect of CAPA
➢This recording is now part of a CONTENT package. Read more...
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