Advanced CAPA & Root Cause Analysis Conference

Agenda

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    • Tuesday, March 26, 2019
    •  
      8:30 AM  -  9:00 AM
      Registration and Breakfast
      9:00 AM  -  9:05 AM
      Welcome
      9:05 AM  -  10:00 AM
      Observed Ongoing CAPA Challenges
      • The CDRH Perspective on CAPA
      • Typical enforcement actions
      • CAPA and new FDA initiatives
      • Where do things usually go wrong?
      • Company struggles with CAPA
      Speakers:
      10:00 AM  -  10:45 AM
      Trending and Triggers

       

      • What do you trend?
      • What tools do you need?
      • What triggers a CAPA?
      Speakers:
      10:45 AM  -  11:00 AM
      Break
      11:00 AM  -  12:00 PM
      CAPA and Risk Management
      • Risk-based criteria for escalation to CAPA
      • 13485:2016
      12:00 PM  -  1:00 PM
      Lunch
      1:00 PM  -  2:30 PM
      Root Cause Analysis - Toolbox & Cast Studies
      • Investigational tools and techniques
      • Case studies
      Speakers:
      2:30 PM  -  2:45 PM
      Afternoon Break
      2:45 PM  -  4:15 PM
      CAPA Verification and Validation
      • Where corrections often go wrong – creating another procedure, adding a form, requiring additional review and approval, etc.
      • “Pressure testing” corrective actions
      • What do you check?Establishing passing criteria
      • Verification and validation of long-term effectiveness
      • Tools and techniques
      Speakers:
      4:15 PM  -  5:15 PM
      CAPA Training and Creating a Positive CAPA Culture
      • Establishing internal CAPA training programs
      • Changing cultural perceptions: CAPA as creative problem-solving and process improvement, not punitive action
      • Motivating and rewarding CAPA ownership and completion
      Speakers:
    • Wednesday, March 27, 2019
    •  
      8:30 AM  -  9:45 AM
      Applying Project Management to CAPA

      Discussion 

      • Defining CAPA team stakeholders and creating an appropriate system and plan
      • Balancing internal auditor tracking requirements with needs for effective CAPA
      • Using project management tools to help CAPA owner plan their investigation and corrective action activities
      Speakers:
      9:45 AM  -  10:00 AM
      Break
      10:00 AM  -  11:00 AM
      Aging CAPAs and CAPAs that Never Close
      • CAPA timelines
      • Ensuring the appropriate scope of CAPAs
      • The challenge of aging CAPAs
      • Review and documentation of aging CAPAs
      • CAPAs that never close
      Speakers:
      11:00 AM  -  11:45 AM
      CAPA and the Supply Chain
      • Supplier responsibilities under FDA
      • Supplier responsibilities under EU MDR
      • Coordinating effective investigations with suppliers
      Speakers:
      11:45 AM  -  12:30 PM
      Connecting CAPA to other Quality Processes
      • Closing the loop
      • Design control
      • Production and process controls
      • Supplier management
      • Management review
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