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

Course is now LIVE. Click below to join the session.

This course helps investigation and quality teams strengthen the scientific rationale behind RCA and CAPA decisions so findings, corrective actions, and effectiveness checks remain evidence-based, measurable, and inspection-ready. This Course is designed for professionals responsible for investigation quality, escalation decisions, CAPA effectiveness, or operational consistency within regulated quality systems.

  • 15 - 16 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 2 Hours - both days
  • FDB3536
  • G. Sundar
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$290  |  One participant (viewer)

$390  |  Team of up to 5 participants

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REGISTER FOR THE COURSE

US $290 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $290 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • G. Sundar
  • Study time : 4 Hours - 2 Modules
  • Skill Level: Intermediate
  • Course ID: TF3536
  • Assessment & Certification Included
  • Ask the Expert

About the Course

RCA and CAPA activities continue to receive close regulatory scrutiny because investigations that appear complete on paper often fail to demonstrate clear reasoning, accurate root cause linkage, or reliable prevention of recurrence. Investigators increasingly evaluate whether conclusions are supported by evidence, whether causal relationships are logically established, and whether corrective actions truly address the conditions that allowed the event to occur. Weak linkage between investigation outcomes, CAPA design, and effectiveness verification remains a recurring inspection concern.

This two-day program focuses on practical investigation decision-making across deviations, OOS/OOT events, complaints, recalls, human error scenarios, and data integrity issues. Participants will apply structured RCA tools including 5 Whys, Fishbone, FMEA, Fault Tree Analysis, and Pareto Analysis within realistic manufacturing and laboratory case situations. The emphasis remains on distinguishing symptoms from true root causes, designing measurable CAPA actions, and maintaining consistency across investigation, documentation, verification, and inspection expectations.

Why take this course?

  • Strengthen investigation logic and root cause clarity:

    Many investigations contain detailed documentation but still fail under review because conclusions are not clearly supported by evidence. This course improves how teams separate symptoms, contributing factors, and true root causes while applying RCA tools appropriately across deviations, OOS/OOT events, complaints, and data integrity investigations.

  • Build CAPA actions that withstand regulatory review:

    Corrective actions frequently fail because effectiveness criteria are vague, remediation is superficial, or CAPA linkage is weak. This course helps participants design measurable corrective and preventive actions, establish stronger verification practices, and maintain consistency from investigation through effectiveness checks under FDA inspection scrutiny.

Who Must Attend

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Operations Departments
  • Regulatory Affairs Departments
  • Validation Departments
  • Auditing/Internal Auditors
  • Laboratory Professionals
  • CAPA Coordinators

Course Agenda

MODULE 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

MODULE 2

CAPA Design and Investigation Verification

  • Managing OOS, OOT, and laboratory investigation complexity through the Phase 1-3 process
  • 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
COURSE DIRECTOR

G. Sundar

G. Sundar brings 35 years of experience in Quality Assurance, Quality Control, Bioequivalence, and pharmaceutical regulations across bulk drugs, formulations, CROs, and laboratory environments. His work includes GMP/GLP audits, Q10 and Q11 implementation, contract manufacturing oversight, and extensive global training related to investigations, CAPA systems, quality tools, and regulatory compliance.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

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Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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