Webinar Title :
Root Cause Analysis in Pharma: Avoiding Superficial Investigations & Developing Effective CAPA
Duration : 90 minutes
Effective Root Cause Analysis is essential for preventing recurring deviations, failures, complaints, OOS/OOT results, and other quality problems in pharmaceutical operations. Yet many investigations stop at immediate causes such as “operator error,” “training deficiency,” or “procedure not followed,” resulting in CAPA that may correct the symptom without addressing the underlying cause.
This 60-minute practical webinar will explore how to move beyond superficial investigations and develop a more structured, evidence-based approach to Root Cause Analysis and CAPA.
Participants will learn how to distinguish between symptoms, immediate causes, contributing factors, and true root causes, apply practical RCA techniques, assess the adequacy of an investigation, and connect root-cause findings to meaningful corrective and preventive actions.
The session will also use a practical pharmaceutical case study to demonstrate how an apparently straightforward investigation can overlook deeper systemic causes.
The webinar is designed to provide a practical framework that teams can take back to their organizations and apply to real investigation and CAPA challenges.
90-Minute Agenda
1. Why Root Cause Analysis Matters in Pharmaceutical Quality
5 Minutes
- Recurring deviations, failures, OOS/OOT and complaints
- Why problems continue despite completed CAPA
- Immediate correction vs. eliminating the underlying cause
- The consequences of weak investigations
2. Why Pharmaceutical Investigations Become Superficial
10 Minutes
- The “operator error” trap
- The “training deficiency” trap
- “SOP not followed” as an incomplete conclusion
- Symptom vs. immediate cause vs. contributing factor vs. root cause
- Stopping an investigation too early
- Common weaknesses in investigation documentation
3. A Practical Framework for Finding the True Root Cause
12 Minutes
- Defining the problem correctly
- Establishing a clear problem statement
- Gathering objective evidence
- Identifying causal relationships
- Using 5 Whys effectively
- Applying Fishbone/Ishikawa analysis
- Recognizing when deeper investigation is required
- Incorporating risk-based thinking
4. From Root Cause to Effective CAPA
13 Minutes
- Correction vs. corrective action vs. preventive action
- Connecting CAPA directly to the identified root cause
- Why retraining alone may not be sufficient
- Developing meaningful corrective actions
- Establishing measurable effectiveness checks
- Preventing recurrence
- Common CAPA weaknesses
5. Practical Pharmaceutical Case Study
12 Minutes
Is “Operator Error” Really the Root Cause?
- Review of a recurring pharmaceutical deviation
- Identifying the apparent cause
- Exploring contributing factors
- Determining what additional evidence should be considered
- Challenging the proposed root cause
- Developing a more effective CAPA approach
6. Key Takeaways & Q&A
8 Minutes
- Five questions every investigator should ask
- Warning signs of a superficial investigation
- Characteristics of an effective CAPA
- Participant questions and discussion
Who Will Benefit
This webinar will benefit professionals involved in pharmaceutical investigations, deviations, quality systems, CAPA and GMP compliance, including:
- Quality Assurance (QA) Professionals
- Quality Control (QC) Professionals
- Deviation & Investigation Teams
- CAPA Owners and Quality Systems Professionals
- GMP Compliance Professionals
- Manufacturing & Operations Personnel
- Quality Managers and Directors
- Production Managers
- Validation Professionals
- Engineering Professionals
- R&D and Process Development Teams
- Regulatory Affairs Professionals
- Audit and Inspection Readiness Teams
-
Site Heads and Functional Leaders responsible for quality
Know Your Faculty (25+ yrs exp.)
Head of Quality Assurance (USA)
Kelly Thomas is a seasoned Quality Assurance and Regulatory Compliance expert with over 30 years of experience in the pharmaceutical, biotechnology, API, and medical device industries. Her expertise includes FDA cGMP compliance, Quality Management Systems (QMS), process validation, technology transfer, supplier quality management, regulatory inspections, and global quality systems.
Kelly has successfully led FDA, EMA, Health Canada, ANVISA, and other international regulatory inspections, supporting API, biologics, sterile injectable, oral solid dosage (OSD), medical device, and combination product manufacturing. She is recognized for strengthening quality systems, driving inspection readiness, implementing Lean Six Sigma initiatives, and helping organizations achieve regulatory compliance while ensuring product quality and patient safety.
