LIVE WEBINAR
Root Cause Analysis for GMP Investigations
Identifying Systemic Failures and Building Effective CAPA
- July 08, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 90 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
Designed for organizations responsible for investigating quality events, evaluating recurring issues, or maintaining corrective action systems across regulated operations.
ABOUT THE COURSE
Investigation teams routinely face decisions about whether observed failures reflect isolated events, contributing factors, or broader process and system weaknesses. This session structures investigation activities, analytical methods, impact evaluation, and CAPA linkage into a repeatable approach for resolving underlying causes.
The session begins with the role of failure investigation within CGMP systems and then follows the progression from problem definition through root cause identification, impact analysis, corrective action development, verification activities, and long-term monitoring. Practical analytical tools and workflow models are used throughout to support consistency and repeatability.
Key Areas Covered
- FDA expectations for failure investigation and CAPA systems
- Structured failure investigation and problem definition
- Root cause analysis using practical investigation tools
- Distinguishing symptoms from systemic causes
- Impact assessment and risk evaluation activities
- Corrective, preventive, and verification actions
- Monitoring effectiveness and sustaining improvements
John E. Lincoln
John E. Lincoln has spent decades helping regulated manufacturers address CAPA deficiencies, quality system remediation, validation challenges, FDA responses, and risk management activities. His experience across quality assurance, regulatory affairs, engineering, and product development provides direct perspective on how organizations identify systemic causes, implement corrective actions, and maintain effective closed-loop investigation processes.
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
Access is provided in a structured and professionally supported format.
- A confirmation email outlines onboarding and next steps
- The complete session recording is delivered through TalkFDA
- Access is granted shortly after purchase so you can begin without delay
- Recording includes the full presentation and instructor-led discussion
- Certificates of completion are issued upon course completion
- Support remains available for any technical or access assistance
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