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.
CPD Hours: 12
Course Content
- Day 1
- Introduction to GMP and the role of an auditor
- The golden rules of GMP auditing: core principles
- Planning and preparing for GMP audits
- Conducting the audit - techniques and best practices
- Workshop - working on the draft audit agenda
- Day 2
- Identifying GMP non-conformities and risks
- Corrective and preventive actions (CAPA)
- Reporting audit findings and communicating results
- Workshop: working on the draft audit report
- Reporting audit findings and communicating results cont.
Speakers
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.
