Presented by
Management Forum
Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor Training Course
Learn to conduct thorough audits, identify non-conformities, and recommend corrective actions while following the Golden Rules of successful GMP auditing.
2-3 June 2025
+ 1-2 October 2025, 5-6 February 2026 »
from £1299
- 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
Navigating thorough and successful GMP audits can be a challenging experience within the pharmaceutical industry. GMP auditors play a vital role in safeguarding public health by assessing and ensuring that manufacturing processes meet stringent regulatory standards. Therefore, Good Manufacturing Practices (GMP) are crucial for ensuring product safety, quality, and efficacy.
This training will equip you with the essential tools, strategies, and best practices needed to excel as a GMP auditor. Whether you are new to auditing or an experienced professional, this specially designed programme will guide you through the core principles that lead to successful GMP audits. You will learn how to effectively assess compliance with GMP standards, conduct thorough audits, identify non-conformities, and recommend corrective actions to drive continuous improvement.
Focusing on the "Golden Rules" for a successful GMP auditor, you will learn that these principles go beyond technical knowledge. They emphasise building strong communication, developing keen observational skills, and fostering a collaborative approach with auditees – all of which are essential for ensuring the highest compliance and quality in manufacturing environments.
By the end of this training, you will have a deeper understanding of the GMP audit process and an increased confidence in conducting audits with objectivity and professionalism. Additionally, you will have enhanced your ability to make impactful decisions that ensure compliance, quality, and safety.
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.
Benefits of attending
- Gain a comprehensive understanding of the "Golden Rules" of GMP auditing and how they apply to the audit process
- Learn how to effectively identify GMP non-conformities, from documentation errors to deviations in manufacturing processes
- Align your auditing skills with global GMP standards, helping you stay compliant with industry regulations
- Understand how to assess audit findings and suggest practical, effective corrective actions
- Develop a risk-based mindset, allowing you to prioritise audit focus areas and address critical compliance issues that could impact product quality and safety
Who should attend
This training will suit those in the following departments:
- Quality Assurance
- Quality Control
- GMP Compliance
- Auditing
- IT
- Regulatory Affairs
- Engineering
- Supply Chain
This course will cover:
Introduction to GMP and the role of an auditor
- Overview of Good Manufacturing Practices (GMP) and their importance
- Understanding the role of GMP auditors in ensuring quality and compliance
- Key regulatory authorities (FDA, EMA, MHRA, WHO, PIC/S, TGA) and their GMP requirements
The golden rules of GMP auditing: core principles
- Rule 1: maintain objectivity and independence
- Rule 2: prepare thoroughly before the audit
- Rule 3: focus on critical areas and risks
- Rule 4: document findings accurately and clearly
- Understanding the importance of these principles in conducting effective audits
Planning and preparing for GMP audits
- How to define audit objectives and scope
- Creating effective audit checklists and planning strategies
- Pre-audit preparations: reviewing documents, data, and previous audit reports
- Communicating expectations with the audit team and auditees
Conducting the audit – techniques and best practices
- Rule 5: effective communication with auditees
- How to ask the right questions and observe processes
- Techniques for assessing facilities, equipment, and quality systems
- How to maintain professionalism and objectivity during the audit
Workshop - working on the draft audit agenda
- Hands-on workshop to practice preparing a GMP audit agenda
Identifying GMP non-conformities and risks
- Rule 6: be thorough in identifying non-conformities
- Techniques for spotting GMP violations and quality issues
- Assessing risks associated with non-conformities and their potential impact on product quality
- Understanding the severity of findings and classifying risks
Corrective and preventive actions (CAPA)
- Rule 7: effective corrective and preventive actions
- Understanding CAPA and its importance in GMP auditing
- How to work with auditees to develop actionable CAPA plans
- Follow-up processes: verifying that corrective actions are implemented
Reporting audit findings and communicating results
- Rule 8: clear and objective reporting of findings
- Best practices for writing audit reports
- How to communicate audit findings effectively to management and auditees
- Handling discrepancies, disagreements, and difficult situations during the report phase
Workshop: working on the draft audit report
- Hands-on workshop to practice preparing a GMP audit report
Reporting audit findings and communicating results cont.
- Rule 9: learn from every audit
- How to build a culture of continuous improvement in the auditing process
- Self-assessment and reflection: improving your auditing skills over time
- How to measure and monitor the effectiveness and efficiency of GMP Audits
- Staying up-to-date with regulatory changes and GMP updates
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
2-3 June 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15599
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 28 Apr
- 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
1-2 October 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15600
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 27 Aug
- 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
5-6 February 2026
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15601
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 01 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 Golden Rules of Being a Successful GMP Auditor 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:
