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Live virtual certificate course

Root Cause Analysis (RCA), Deviations & CAPA Effectivenes for FDA-Regulated Industries

A practical CAPA-focused training for GMP professionals who investigate deviations, identify true root causes, and build inspection-ready corrective action strategies.

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GMP Investigations CAPA Strategy Deviation Control FDA Readiness
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Purchase Options

Select the option that best fits your attendance needs.

Best Value

Early Bird One Dial-in One Attendee - Live

$1,495

One log-in for the live 4 half-day virtual seminar for one participant, including presentation materials, certificate of completion, and Q&A access.

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Flexible Access

Simulation Live - 1 Year Access

$1,498

Twelve-month single-user recorded access to the full seminar archive, including Q&A, presentation materials, audio recording, and transcript.

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For Teams

Live Group up to 2-5 Participants

$3,995

Group access for 2-5 participants with live seminar log-ins, presentation materials, certificates of completion, Q&A access, and free on-demand access.

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4-Day Course Agenda

Best Root Cause Analysis Training (RCA), Investigations & CAPA Workshop

Total Duration: 12 Hours | 3 Hours Per Day

3 Hours

Investigation & CAPA Fundamentals

Build a strong foundation and understand 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

Interactive Learning

  • Event characterization exercise
  • Identifying cognitive bias in investigations
  • Group discussion on investigation failures
3 Hours

Investigation Excellence & Root Cause Analysis

Learn how to identify the true root cause, not just symptoms.

Investigation Techniques

  • Effective data gathering strategies
  • Interviewing and evidence collection
  • Data integrity considerations
  • Data mining and trend analysis
  • GMP transactional mapping

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

Interactive Learning

  • GMP awareness activity
  • Root cause brainstorming workshop
  • Investigation mapping exercise
3 Hours

CAPA Development & Effectiveness

Turn root causes into strong, audit-ready CAPAs.

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

Effectiveness Checks

  • Defining measurable CAPA success metrics
  • CAPA efficacy evaluation methods
  • Verification vs validation
  • Monitoring long-term effectiveness
  • Preventing recurrence of deviations

Interactive Learning

  • CAPA effectiveness review exercise
  • Weak vs strong CAPAs group activity
  • CAPA planning workshop
3 Hours

Case Studies & Inspection Readiness

Apply learning to real pharmaceutical scenarios.

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

Course Overview

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.

Learning Objective

  • How to conduct effective, unbiased investigations
  • Proven tools and techniques for Root Cause Analysis (RCA)
  • How to distinguish symptoms vs true root causes
  • Designing strong corrective and preventive actions (CAPA)
  • Applying risk-based approaches (ICH Q9 principles)
  • Using data, trends, and statistical thinking in investigations
  • Preparing inspection-ready documentation and reports

Who Will Benefit

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

Know Your Faculty (25+ yrs exp.)

Kelly Thomas Head of Quality Assurance (USA)

A seasoned Quality Assurance, Quality Control, and Regulatory Compliance leader with 25+ years of experience across API, biologics, medical devices, and combination products. Extensive expertise in aseptic and terminally sterilized manufacturing, along with all major dosage forms.

Proven track record of leading facility start-ups and successfully managing global regulatory inspections, including FDA and international agencies. Known for building strong quality systems, supplier management programs, and audit readiness frameworks.

👉 Brings practical, inspection-ready insights to help you strengthen compliance and avoid costly mistakes.


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