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Deviations, CAPA and Change Control

Deviation handling often determines whether quality systems demonstrate control or reveal recurring gaps during routine oversight and formal inspection review. This session structures investigation rigor, CAPA sustainability, and change control discipline into an integrated process aligned with 21 CFR 820.100 expectations.

Designed for professionals accountable for investigation quality, corrective action effectiveness, and controlled system change.

📅  March 11, 2026    |  ðŸ•’  11 AM Eastern Time US     |  ðŸ•’  3 PM GMT    |  âŒ› 2 Hours


How This Session Is Structured

The session begins with deviation classification and investigation scoping, then progresses into structured root cause methods and evidence-based reporting. It connects corrective action development to effectiveness checks and change control governance, concluding with trending and metrics that reinforce long-term oversight and continuous improvement.

Key Areas Covered:

✔ Deviation and nonconformance management workflows

✔ Structured root cause analysis methods

✔ Writing investigation reports supported by evidence

✔ CAPA development, implementation, and effectiveness checks

✔ Risk assessment tools supporting corrective actions

✔ Change control requirements and governance discipline

✔ Trending, metrics, and sustained inspection readiness under 21 CFR 820.100

Course Director

Charles H. Paul

Charles H. Paul brings over 25 years of experience advising regulated manufacturers on investigation systems, documentation controls, and operational compliance. His consulting work includes strengthening deviation processes, CAPA programs, and change management systems across pharmaceutical and medical device organizations, supporting structured, evidence-based quality oversight aligned with regulatory expectations.


What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

  • A confirmation email outlines onboarding details and next steps
  • Access credentials are shared in advance so you are prepared before the session
  • Handouts (where applicable) are provided ahead of time
  • The training is delivered live via Webex with interactive participation and Q&A
  • Certificates of completion are issued following the session
  • For live + recording access, post-session availability is provided through TalkFDA
  • Event support remains available for any access or logistics assistance