Course overview
This training course has been specifically designed to help you step back and look at GMP differently - not as a set of regulations to follow, but as a framework that can be evaluated from multiple perspectives to strengthen processes and enhance performance.
As the pharmaceutical industry continues to evolve in response to technological advancements, increasingly rigorous regulatory expectations, updated and expanding guidelines, and the needs of the end-user patient, the importance of effective GMP implementation has never been greater. Simply complying is no longer enough; organisations must ensure their systems are robust, efficient, and future-focused.
During this course, core GMP topics are explored from a fresh and practical perspective. You will refresh your existing knowledge while gaining new insights and expertise that support stronger application in the workplace. The course encourages broader thinking around GMP implementation, helping you better understand how to interpret, apply and optimise regulatory requirements within your organisation.
To reinforce learning, the sessions include scenario-based discussions and practical examples. In addition, delegates receive complementary bonus documents alongside the training materials to support implementation of newly learned techniques back at work.
By the end of the course, you will have enhanced your GMP knowledge and gained practical tools to apply regulatory requirements more effectively, confidently, and strategically.
CPD Hours: 12
Course Content
- Day 1
- Introduction to GMP regulations
- Management responsibility
- Lessons learnt from other industries
- Learning organisation and quality culture
- Personnel and training expectations in GMP
- Documentation pitfalls
- Group exercise: let’s improve our SOPs in microbiology laboratory
- Deviation management and CAPAs
- GMP behaviour models
- Day 2
- A new validation approach
- Knowledge-based change control
- Before and after shutdown
- Complaints and recalls
- Group exercise: audit shortcuts
- Technology transfer best practices
- Outsourcing
- Do you know your GMP compliance score?
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.
