Presented by
Management Forum
How to Pass International Health Authority Inspections In-house Training
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.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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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.
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 a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.
His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.
Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:
- GMP/GDP audits and supplier qualification
- Validation, qualification, and quality risk management (ICH Q9)
- Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
- Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
- Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
- Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards
Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.
A prolific author, Mustafa's works include:
- “Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
- “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices
Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.
Turkey
- İlsan iltaş
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 team to discuss your requirements:
