Presented by
Management Forum
How to Pass International Health Authority Inspections Training Course
FDA, MHRA, PIC/S, ANVISA, WHO, EMA Audits
This training course prepares professionals in pharmaceuticals, healthcare, and manufacturing to navigate regulatory inspections by major health authorities including the FDA, MHRA, WHO, and EMA.
19-20 June 2025
+ 8-9 October 2025, 12-13 February 2026 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
You may also be interested in...
- Golden Rules of Being a Successful GMP Auditor
- How to Pass International Health Authority Inspections
- How to Manage Internal GMP Audits
- How to Audit Pharmaceutical Suppliers (Material and Service)
- How to Deal with Difficult Situations in Audits
- How to Interview During Audits
- How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits
Part of Audit Essentials: From Interviews to Inspections series:
Led by industry expert Mustafa Edik, this comprehensive new training series is designed for professionals in the pharmaceutical industry who want to master GMP audits. Learn how to conduct thorough audits, manage supplier assessments, and confidently handle regulatory inspections. The courses in this series cover everything from raw material audits and GMP compliance to overcoming challenges and maintaining audit readiness for major health authorities like the FDA, EMA, and WHO. Additionally, you’ll gain crucial knowledge of Good Distribution Practices (GDP) and Good Storage Practices (GSP) to ensure product quality and safety. Ready to elevate your auditing expertise and stay ahead of industry standards? Enrol today!
Course overview
Designed to equip you with the knowledge and skills necessary to excel in inspections by major health authorities, including the FDA, MHRA, PIC/S, ANVISA, WHO, and EMA, this training course serves as a pathway to mastering international health authority inspections and setting your organisation up for success. In today's global marketplace, pharmaceutical companies, healthcare organisations, and manufacturers must navigate complex regulatory landscapes to ensure product safety, quality, and compliance.
Whether you are preparing for your first inspection or seeking to enhance your existing compliance strategies, this training course offers actionable insights to help you pass international inspections with confidence. It focuses on understanding the specific requirements of each health authority and the best practices to meet their expectations.
By the end of this course, you will be empowered to manage inspections effectively, proactively address potential compliance issues, and maintain continuous readiness for audits. Our goal is to ensure you are fully prepared to navigate regulatory inspections and uphold the highest standards of quality and safety in your operations.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
Who should attend
This course will suit those in the following departments:
- Quality Assurance
- Quality Control
- GMP Compliance
- Auditing
- IT
- Regulatory Affairs
- Engineering
- Supply Chain
Benefits of attending
- Gain in-depth knowledge of the specific inspection criteria and requirements of major health authorities, including the FDA, MHRA, PIC/S, ANVISA, WHO, and EMA
- Learn proactive strategies to maintain inspection readiness throughout the year
- Discover best practices for maintaining a robust quality management system, proper documentation, and self-inspections
- Master how to manage interactions with health authority inspectors effectively
- Understand the common pitfalls in inspections and how to address them
- Discuss how to pass inspections efficiently with minimal disruptions to your operations
- Stay ahead of evolving regulations and industry standards, ensuring your organisation remains in full compliance with the latest requirements, ultimately safeguarding the quality and safety of your products
This course will cover:
Introduction to regulatory inspections
- Understanding the importance of health authority inspections in ensuring safety and quality
- Overview of the major international regulatory bodies (FDA, MHRA, PIC/S, ANVISA, WHO, EMA)
- Key similarities and differences between the authorities’ requirements
Preparing for audits: key principles
- The inspection lifecycle: from preparation to post-inspection follow-up
- Key concepts of regulatory compliance and risk management
- Documentation requirements and maintaining effective quality systems
- Self-inspection processes: how to self-assess and identify potential weaknesses
Understanding FDA inspections
- Key requirements for FDA inspections
- Focus areas: Good Manufacturing Practices (GMP), 21 CFR compliance, and safety standards
- Common pitfalls and how to avoid them
- Case studies of successful FDA Inspections
Understanding MHRA and EMA inspections
- Key focus areas for MHRA and EMA Inspections
- Differences in approach: EU regulations vs. UK regulations post-Brexit
- Compliance with EU GMP and EMA’s approach
- Real-life examples from past MHRA and EMA inspections
Understanding PIC/S and WHO inspections
- Introduction to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and its global impact
- WHO’s role in international health and safety standards
- Key regulations and their impact on global compliance
- Handling PIC/S and WHO Inspections effectively
Workshop - how to respond to FDA 483s
Understanding ANVISA inspections
- Overview of Brazil’s ANVISA and its regulations for pharmaceutical manufacturers
- Differences in ANVISA’s inspection style and how to prepare
- How to meet local regulations while maintaining international standards
- A successful ANVISA Inspection
Inspection communication and interaction with inspectors
- Best practices for effective communication with inspectors
- How to handle difficult situations during an inspection
- Understanding inspection findings and addressing non-conformances
- Building a cooperative relationship with regulatory bodies
- How to respond to inspection findings and observations
- Training and development strategies for teams
Workshop - problems between PIC/S and other health authorities
Preparing for inspections: simulation and role play
- Practical session: Role-playing common inspection scenarios
- Mock inspections to practice handling inspectors and responding to findings
- Q&A and feedback session to refine communication skills
Remote inspections and audits
- Are remote inspections really necessary?
- What are the points to consider when preparing for remote inspections?
- How does the Health Authority approach remote inspections?
- What are the lessons of Covid-19?
Mustafa Edik
Mustafa Edik is an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
19-20 June 2025
Live online
09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 15602
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 15 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
8-9 October 2025
Live online
09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 15603
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 03 Sep
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
12-13 February 2026
Live online
09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
04:30-12:15 New York (UTC-05)
Course code 15604
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 08 Jan
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Run How to Pass International Health Authority Inspections Live online for your team
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
