🎤  Edwin Waldbusser    |  📅  Recording Available    |  🕒  60 Minutes

Areas Covered in the Session : 

  • Sources of information (complaints)
  • Information gathering & proactive information gathering
  • Information evaluation (is it a Complaint, is it a CAPA, should it be investigated)
  • Risk analysis applied to CAPA
  • Root cause determination
  • CAPA Investigation Report & CAPA action Plan
  • Verification/ Validation of CAPA action
  • Post closing effectiveness check
  • CAPA program metrics


Learn how to manage the Complaint handling and Corrective and Preventative Action (CAPA) process effectively with our informative webinar. We cover the entire CAPA process, from information gathering to MDR and Recall decision-making to final CAPA closing, including required post-closing effectiveness evaluation. Our course also addresses often-neglected Preventative Action and post-distribution product monitoring, including customer surveys. We discuss the integration of manufacturing non-conformities with the CAPA program and provide templates of the Complaint Evaluation form and the Corrective Action Plan handouts for attendees. As two of the most crucial areas for ensuring medical device safety and efficacy, Complaint handling and CAPA are among the top five areas where the FDA finds problems during inspections and issues 483s. It is crucial for medical device developers to have a strong understanding of the complicated Complaint and CAPA process and strike a balance between too many and too few CAPAs.

Who Should Attend:

  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability engineers
  • Risk managers
  • Design Engineering Managers
  • Medical Device Engineering
  • Quality Assurance
  • Regulatory
  • Management

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