RCA & CAPA: What Inspectors look for Beyond a “Well-Documented” Investigation

2-DAY MODULAR WEBINAR

RCA & CAPA: What Inspectors look for

Beyond a “Well-Documented” Investigation

When investigation conclusions must hold up across deviations, OOS events, and CAPA reviews, two focused days of structured analysis become operationally necessary. This seminar strengthens investigation reasoning, root cause linkage, CAPA verification, and effectiveness evaluation through applied manufacturing and laboratory investigation scenarios.

Designed for professionals responsible for investigation quality, escalation decisions, CAPA effectiveness, or operational consistency within regulated quality systems.

COURSE Structure & AGENDA

The program begins with investigation foundations, analytical reasoning, and structured RCA tool application across realistic manufacturing and laboratory cases. Day 2 extends those decisions into complex investigation environments, including data integrity and human error scenarios, before connecting outcomes to CAPA design, effectiveness verification, and inspection-facing documentation expectations.

DAY 1

Investigation Foundations and Root Cause Evaluation

Identifying investigation triggers across quality system events
Separating contributing factors from true root causes
Applying 5 Whys and Fishbone methods appropriately
Using FMEA and Fault Tree Analysis practically
Prioritizing systemic issues through structured risk evaluation

DAY 2

CAPA Design and Investigation Verification

Managing OOS, OOT, and laboratory investigation complexity
Evaluating data integrity and computerized system concerns
Addressing human error without superficial remediation strategies
Building measurable CAPA effectiveness verification approaches
Structuring investigation reports with evidence-based rationale

FACULTY

G. Sundar

G. Sundar brings more than 35 years of experience across pharmaceutical quality systems, investigations, GMP auditing, laboratory oversight, and regulatory compliance. His extensive work conducting global GMP and GLP audits, implementing Q10 and Q11 systems, and delivering over 1,000 industry trainings gives him direct operational perspective on how RCA and CAPA decisions are evaluated during inspections.

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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