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.

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:

Day 1
Day 2

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 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.

More details

Previous customers

United Kingdom

Ethypharm UK Ltd

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

Contact us

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:

Golden Rules of Being a Successful GMP (Good Manufacturing Practice) Auditor In-house Training