2-DAY MODULAR COURSE
RCA and CAPA: What Inspectors look for Beyond a “Well-Documented” Investigation
EXCLUSIVE OFFER: Get your team to attend for just $ 390. Individual registrations available too.
- June 15 - 16, 2026
- 11 AM - 1 PM (Eastern Time US)
- 3 PM - 5 PM (GMT)
- 2 Days
- G. Sundar
- Q&A | Ask The Expert
- Live + Post-live Continued Learning
- Presentation Handout & Templates
- Assessment & Certification Included
ABOUT THE COURSE
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.
After You ReGISTER
After you register your seat, our team organizes everything is organized for you; from access to certification – “from one place”.
- You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.
- Your TalkFDA course page becomes your central hub where you can join the session, access materials, and manage your learning.
- At the scheduled time, click Join Session and you’ll be connected to the live Webex session with the instructor.
- After the session, the playback becomes available on the same course page so you can revisit important sections.
- Complete the course and your certificate is unlocked automatically in your learning history.
- Everything related to your course: access, materials, playback, and certification – lives in one place.
For Teams Seeking Deeper Implementation Support
This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.
FDB3536
© All rights reserved