Introduzione
Is Human Error the True Root Cause of a Deviation?
Human error is frequently identified as the cause of deviations, quality events and operational failures. However, simply attributing an event to an individual may prevent organisations from identifying the underlying process, task or organisational conditions that made the error possible.
This course introduces a practical Human Factors approach to understanding why people make mistakes and how those mistakes can be prevented. Participants will explore the relationship between the individual, the task and the organisation, learn how to distinguish different categories of human error, and evaluate whether “human error” can genuinely be considered the root cause of a deviation.
The course also examines current regulatory expectations. In particular, it reinforces the expectation that process, procedural and system-related causes should be adequately investigated before a deviation is attributed to human error.
1. Understanding Human Error
- Why people make mistakes
- Human Factors and the interaction between the individual, the task and the organisation
- Common human error drivers
2. Categorising Human Errors
- Different types of human error
- Understanding why errors occur
- Using error categorisation to support investigations and CAPA decisions
3. Human Error Prevention
- Practical strategies for reducing errors
- Task and process design
- Error-proofing, attention mechanisms and organisational barriers
4. Human Error from a Regulatory Perspective
- FDA and EU GMP expectations
- Human error within deviation investigations
- When human error can and cannot be considered the root cause
- Examples of regulatory findings related to human performance
5. From Individual Error to System Weakness
- Active errors and latent organisational conditions
- The role of procedures, equipment, work environment and management systems
- Building stronger barriers against recurrence
6. Practical Workshops
- Categorisation of human errors
- Review of deviation investigations
- Assessment of whether human error is the true root cause
- Identification of more effective corrective and preventive actions
This course is designed for professionals working in regulated life science organisations who are involved in quality events, deviations, investigations, CAPAs and operational activities.
It is particularly relevant for those who actively contribute to investigations, as well as for managers and operational professionals who want to better understand the factors that can lead to human error and learn how to effectively address and reduce them.
The course is particularly suitable for:
• Quality Assurance and Quality Control professionals
• Manufacturing and Operations personnel
• Engineering and Technical Services personnel
• Validation professionals
• Investigation and CAPA owners
• Supervisors and managers
• Internal auditors and compliance professionals
• Subject Matter Experts involved in investigations
Participant’s experience
A basic understanding of GMP and deviation management is recommended.
Previous specialist knowledge of Human Factors is not required.
This is an interactive, instructor-led training course with practical workshops.
The methodology combines Human Factors concepts, regulatory expectations, practical examples, group discussion, error-categorisation exercises and review of real deviation and regulatory scenarios. The course includes workshops specifically designed to challenge whether “human error” is genuinely the root cause of an event.
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 | 29 June 2027 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 01 July 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 08 June 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.
