Introduzione
Advanced Investigations, Root Cause Analysis and CAPA Effectiveness
A strong investigation process is essential for understanding quality events, identifying their true causes and preventing recurrence. Effective investigations should focus on understanding what happened, why it happened and how it can be prevented, rather than simply assigning blame.
This practical course provides a structured approach to deviation investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPAs), and CAPA effectiveness checks. Participants will learn how to clearly define and scope problems, collect and analyse relevant information, evaluate recurrence and risk, identify root and contributing causes, and establish actions that directly address the identified causes.
Particular attention is given to human error investigations, helping participants move beyond automatically assigning “human error” as the root cause and instead evaluate the individual, task, process and organisational factors that may have contributed to an event.
The course concludes with practical guidance on designing meaningful CAPAs and effectiveness checks to demonstrate that actions have genuinely prevented recurrence.
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Fundamentals of Investigations
- Purpose and regulatory expectations
- Problem definition, scope and impact assessment
- Immediate actions and risk-based classification
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Conducting an Effective Investigation
- Data collection and fact-based analysis
- Investigation teams and responsibilities
- Review of recurrence, trends and relevant historical information
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Root Cause Analysis
- Root, direct and contributing causes
- Avoiding superficial conclusions
- Confirming and documenting the true root cause
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Root Cause Analysis Tools
- Process mapping and SIPOC
- Five Whys and Fishbone analysis
- Pareto and other supporting analysis tools
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Establishing Effective CAPAs
- Correction versus corrective and preventive action
- Linking CAPAs to root causes
- Designing practical, risk-based and sustainable actions
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CAPA Effectiveness
- Defining meaningful effectiveness checks
- Monitoring recurrence
- What to do when a CAPA is not effective
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Practical Workshop
- Investigation and RCA exercises
- Human error assessment
- CAPA development and effectiveness review
This course is designed for professionals involved in pharmaceutical quality systems, investigations, CAPA management and continuous improvement.
It is relevant both for professionals who are starting to participate in investigations and for experienced personnel looking to strengthen the robustness and effectiveness of their investigation and CAPA processes.
The course is particularly suitable for:
- Quality Assurance professionals
- Quality Control and laboratory personnel
- Manufacturing and Operations professionals
- Engineering and Technical Services personnel
- Validation professionals
- Regulatory Affairs professionals involved in compliance activities
- Deviation and investigation owners
- CAPA coordinators
- Subject Matter Experts involved in investigations
- Supervisors and managers responsible for quality events
- Internal auditors and compliance professionals
Participant Experience
A basic understanding of GMP and pharmaceutical quality systems is recommended.
Previous experience conducting formal investigations or Root Cause Analysis is useful but not required.
This is an interactive, instructor-led workshop with a strong focus on practical application.
The training combines key regulatory and quality-system concepts with case studies, group discussions and hands-on exercises on Root Cause Analysis, human factors, CAPA design and effectiveness checks.
Participants will work on realistic deviation and investigation scenarios, applying RCA tools and reviewing investigations from a regulatory inspector perspective.
Docente/i
Andrés Gola Isasi
Andres Gola Isasi is a Life Science Regulatory Compliance professional with extensive experience in the pharmaceutical, biotechnology and medical device industries. His expertise covers Regulatory Affairs, Quality Assurance, GMP compliance, investigations, Root Cause Analysis, CAPA systems, Human Factors and regulatory inspections.
Throughout his career, he has supported international life science organisations in quality and regulatory projects, including deviation investigations, CAPA improvement, inspection readiness, remediation activities and quality-system optimisation. He also combines his consulting experience with university teaching and professional training in Regulatory Affairs, Quality and Project Management.
Online Training – 2 modules
MODULE 1 | 28 September 2027 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 30 September 2027 from 2:30 pm to 5:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 07 September 2027)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.