About
Advanced FDA Inspections and US cGMP Compliance Practical Inspection Readiness and Pre-Approval Inspection Management
Companies manufacturing pharmaceutical products for the US market must understand not only the applicable FDA regulations, but also how the Agency interprets and assesses compliance during inspections.
This course provides participants with a practical understanding of the FDA regulatory framework, US current Good Manufacturing Practices (cGMPs), and the way FDA investigators approach pharmaceutical manufacturing inspections. Attention is given to FDA Pre-Approval Inspections (PAIs), including their objectives, areas of focus, inspection management practices, employee interaction with investigators, and the potential consequences of non-compliance.
The course combines regulatory knowledge with practical inspection-readiness concepts to help participants understand what FDA inspectors expect and how organisations should prepare for and manage an FDA inspection.
-
Introduction to the FDA Regulatory Framework
- FDA structure, responsibilities and regulatory authority
- Overview of the US regulatory framework and 21 CFR
- Key FDA guidance and compliance expectations
-
US cGMP Requirements
- Fundamental principles of pharmaceutical cGMPs
- Key quality-system and manufacturing expectations
- Main differences between US and EU GMP approaches
-
FDA Inspection Approach
- How FDA inspections are structured
- Key systems and areas typically assessed
- Common inspection findings and compliance concerns
-
Pre-Approval Inspections
- Purpose and scope of a PAI
- Main objectives and areas of focus
- Relationship between commercial readiness, CMC information and Data Integrity
-
Inspection Readiness and Management
- Organisational preparation for an FDA inspection
- Roles, responsibilities and document management
- Good Inspection Management Practices
-
Interaction with FDA Investigators
- Appropriate behaviour during interviews and plant tours
- Managing questions, requests and documentation
- Common mistakes to avoid during an inspection
-
Post-Inspection Activities
- Inspection observations and Form FDA 483
- Response to observations
- Potential consequences of non-compliance
-
Practical Workshop
- Inspection scenarios
- Interview and audit techniques
- Application of inspection-management principles
This course is designed for professionals working in pharmaceutical organisations that manufacture, test, package, release or support products intended for the US market.
It is relevant both for professionals who want to build a solid understanding of the US regulatory and cGMP framework and for experienced personnel involved in FDA inspection readiness, preparation and management.
The course is particularly suitable for:
- Quality Assurance and Quality Control professionals
- Regulatory Affairs professionals
- Manufacturing and Operations personnel
- Laboratory and analytical personnel
- Engineering, Validation and Technical Operations professionals
- Pharmaceutical Development and Technology Transfer teams
- Site and department managers
- Subject Matter Experts involved in FDA inspections
- Professionals responsible for inspection readiness, internal audits and regulatory inspections
Participant Experience
A basic understanding of pharmaceutical GMP principles and quality systems is recommended.
Previous experience with FDA inspections is not required.
This is an interactive, instructor-led training course combining regulatory and cGMP concepts with practical inspection-readiness activities.
The training uses real-life inspection scenarios, FDA observations, group discussions and hands-on exercises to explore inspection management, appropriate behaviours and effective interaction with FDA investigators.
Participants will practise audit and interview techniques, including how to recognise and respond to different questioning approaches used during inspections.
Lecturers
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 | 23 February 2027 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 25 February 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 02 February 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.
Register
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.