Course overview
Many pharmaceutical manufacturers tend to describe GMP practices as the rules personnel must follow during production and the recording of production steps. However, GMP is a comprehensive set of standards in which every step of all processes, including pharmaceutical production and R&D activities throughout the product life cycle, is validated and documented.
Historical GMP failures have caused significant tragedies for many companies. Today, any country that prioritises patient health and safety permits the production, import, and sale of pharmaceutical products only in compliance with internationally recognised current GMP standards. GMP (Good Manufacturing Practices) is often referenced as cGMP (current Good Manufacturing Practices) in alignment with FDA terminology. The ‘c’ in cGMP stands for ‘current,’ emphasising that these rules are continuously updated and dynamic, rather than following a ‘produce what is available’ approach. Health authorities remind manufacturers that staying up-to-date is a regulatory requirement.
This distinguished GMP Update training covers updates across all sections of the GMP Guide, incorporating innovations from EMA, PIC/S, FDA, WHO, ANVISA, MHRA, and other regulatory bodies. Participants will also explore the latest developments in concept papers, draft articles, and international GMP guidance, ensuring a complete and current understanding of global GMP expectations.
CPD Hours: 1
Course Content
- Day 1
- Brief history of GMP
- Part 1 - APIC, USP, ICH updates
- Part 2 - FDA, EMA, WHO and other health authority updates
- Q&A session
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.
