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3-Day Virtual Seminar - Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy (ONLINE EVENT: December 8-10, 2026)- Product Image
3-Day Virtual Seminar - Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy (ONLINE EVENT: December 8-10, 2026)- Product Image
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3-Day Virtual Seminar - Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy (ONLINE EVENT: December 8-10, 2026)

  • Training

  • Dec 8th 12:00 - Dec 10th 17:00 EST
  • World Compliance Seminar
  • ID: 6290514
Description Jump to:
In today’s highly regulated pharmaceutical environment, ineffective investigations and weak CAPA systems remain one of the leading causes of FDA observations and compliance failures.

This practical, results-driven training is designed to help professionals identify true root causes, avoid recurring deviations, and implement robust, inspection-ready CAPA strategies.

You will gain a clear understanding of how to move beyond superficial fixes and develop data-driven, scientifically sound solutions that stand up to regulatory scrutiny.

What Attendees Will Get

Professional Certificate & Continuing Education

  • 12 Hours of Live Virtual Training
  • Practical RCA & CAPA Techniques
  • Real-World Pharma Case Studies
  • Interactive Q&A with Industry Expert
  • Presentation Slides & Course Materials
  • FDA & GMP Compliance Insights
  • Investigation & Risk Assessment Skills
  • CAPA Effectiveness Strategies
  • FDA Inspection Readiness Knowledge
  • Certificate of Completion
Strengthen your RCA and CAPA capabilities, improve investigation effectiveness, and reduce repeat compliance issues before your next FDA inspection. Professionals who can conduct strong investigations and implement effective CAPA systems play a critical role in reducing compliance risk and strengthening quality systems.

Course Content

Day 1: Investigation & CAPA Fundamentals
Build a strong foundation in GMP investigations, CAPA systems, and regulatory expectations.
Understanding Investigations
  • What is an investigation?
  • Purpose of GMP investigations
  • Common investigation mistakes
  • Building a quality-focused investigation culture
CAPA Fundamentals
  • Correction vs corrective action vs preventive action
  • Understanding the CAPA lifecycle
  • CAPA workflow and documentation requirements
  • Why CAPA systems fail in organizations
Regulatory Expectations
  • FDA expectations for investigations and CAPA
  • ICH guidelines and global regulatory trends
  • Adulteration and compliance risk
  • Common FDA observations related to weak investigations
Investigation Techniques
  • Effective data gathering strategies
  • Interviewing and evidence collection
  • Data integrity considerations
  • Data mining and trend analysis
  • GMP transactional mapping
Interactive Learning
  • Event characterization exercise
  • Identifying cognitive bias in investigations
  • Group discussion on investigation failures
Day 2: Investigation Excellence & Root Cause Analysis
Learn structured RCA methods, risk assessment tools, and how to identify true root causes instead of symptoms.
Root Cause Analysis
  • Structured RCA methodologies
  • Identifying contributing vs root causes
  • Signal detection and analysis
  • Scientific thinking using the null hypothesis concept
RCA Tools & Risk Assessment
  • 5 Whys
  • Fishbone / Ishikawa analysis
  • Fault tree analysis
  • FMEA fundamentals
  • ICH Q9 quality risk management principles
CAPA Planning & Strategy
  • Linking root cause findings to CAPA actions
  • Designing sustainable corrective actions
  • Building preventive action strategies
  • Avoiding weak or superficial CAPAs
Execution & Implementation
  • Applying DOE concepts for robust solutions
  • Change management considerations
  • Cross-functional CAPA execution
  • Managing implementation timelines and ownership
Interactive Learning
  • GMP awareness activity
  • Root cause brainstorming workshop
  • Investigation mapping exercise
Day 3: CAPA Effectiveness, Case Studies & Inspection Readiness
Evaluate CAPA effectiveness, apply learning to real pharmaceutical scenarios, and prepare for FDA inspection questions.
Effectiveness Checks
  • Defining measurable CAPA success metrics
  • CAPA efficacy evaluation methods
  • Verification vs validation
  • Monitoring long-term effectiveness
  • Preventing recurrence of deviations
Real-World Case Studies
  • Product mix-up complaint investigation
  • Tablet defect / quality issue scenario
  • Media fill failure investigation
  • Deviation trending and escalation examples
Hands-On Workshop
  • End-to-end deviation to RCA to CAPA exercise
  • Investigation documentation practice
  • Group discussion and solution development
  • Risk-based decision-making exercises
FDA Inspection Readiness
  • Presenting investigations to FDA inspectors
  • Handling regulatory questions confidently
  • Defending CAPA effectiveness during audits
  • Common documentation gaps observed by regulators
Final Wrap-Up
  • Key takeaways and implementation strategies
  • Expert-led live Q&A session
  • Certificate of completion discussion

Speaker

Kelly Thomas

Who Should Attend

This is an informative and interactive seminar for professionals in the pharmaceutical, biological, and medical device industries who conduct deviations, Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) investigations, especially for professionals in the following disciplines:
  • Quality Control Analysts
  • R&D
  • Quality Assurance
  • Manufacturing
  • Product/Process Development
  • Engineering

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