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

RCA and CAPA continue to draw close scrutiny during FDA inspections, not because teams lack documentation, but because the underlying rationale often does not fully explain why the issue occurred or how recurrence is prevented. This program focuses on how investigations are actually assessed, where documented work may appear complete but still lacks clarity, linkage, or depth under review.

The session centers on practical investigation decisions across deviations, OOS/OOT, complaints, and data integrity events. You will work through how experienced professionals connect triggers to true root causes, apply the right analytical tools without overreach, and translate findings into CAPA that is measurable, relevant, and verifiable. The focus is on maintaining alignment from investigation through effectiveness checks in a way that holds up during inspection.

| Learning Methodology

This program is structured around realistic investigation scenarios from manufacturing and laboratory environments. Participants will apply RCA tools such as 5 Whys, Fishbone, FMEA, and Fault Tree Analysis to structured case situations, focusing on how decisions are made, not just which tools are used. The emphasis is on developing clear, evidence-based reasoning that connects investigation outcomes to CAPA design and verification.

| Key Takeaway

You will understand how to move from deviation or failure events to clearly supported root causes without relying on assumptions or superficial conclusions. The session builds clarity on linking RCA outcomes to CAPA actions, defining measurable effectiveness criteria, and maintaining consistency across investigation, documentation, and verification. It also provides perspective on how inspection observations and regulatory expectations shape how investigations are reviewed.

| Agenda:

DAY 1:

Module 1: The Foundation of Failure Investigation

• Regulatory Landscape: Understanding why RCA and CAPA are major regulatory focus areas.
• The Investigation Trigger: Managing OOS, OOT, Deviations, Complaints, and Recalls.
• Impact Assessment: Determining the potential impact of failures on pharmaceutical products (API and Formulation).

Module 2: Advanced RCA Tools & Techniques

• Distinguishing the "Why": Separating symptoms and contributing factors from true root causes.
• The Toolbox in Practice:
  • 5 Whys: Moving past superficial issues.
  • Fishbone (Ishikawa) Diagrams: Visualizing causal relationships.
  • Pareto Analysis: Prioritizing systemic issues.
  • Fault Tree Analysis (FTA) & FMEA.

DAY 2:

Module 3: Specialized Investigation Scenarios

• Laboratory Failures: Deep dive into OOS, OOT, and OOE investigations and the Phase 1-3 process.
• Data Integrity: Investigating computerized system violations, trail injections, and integration anomalies.
• Human Error: Handling causal factors and effective remediation strategies.

Module 4: Designing Effective CAPA & Effectiveness Checks

• Corrective vs. Preventive: Understanding the critical distinction for targeted strategies.
• Effectiveness Verification: Establishing measurable criteria to confirm that implemented solutions truly resolve the issue.
• Documentation: How to write a scientific Failure Investigation Report (FIR) that regulators trust.

| Who Should Attend

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Operations Departments
• Regulatory Affairs Departments
• Compliance Departments
• Validation Departments
• Auditing/Internal Auditors
• Laboratory Professionals
• CAPA Coordinators
• Site Heads and Directors of Quality

Course Director: G. SUNDAR

G. Sundar is a quality practitioner with vast 35 years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines. He has conducted more than 200 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical laboratories, 10 Clinical research CROs. He has also conducted 1000 plus trainings Asia, US, EU, Middle East and South-East Asia. Mr. Sundar Ganesan is the Director and Senior Consultant at PharmQA Compliance Services.