Course overview
In the rapidly evolving pharmaceutical and biotechnology sectors, maintaining a robust, compliant, and forward-looking Good Manufacturing Practice (GMP) framework is not just a regulatory necessity, it is a core business driver.
This GMP Advanced Master Class is designed for experienced industry professionals who want to move beyond basic compliance and master the complexities of modern quality systems. The programme bridges the gap between traditional GMP principles and cutting-edge advancements, including ATMPs (Advanced Therapy Medicinal Products), automated systems, data integrity, and proactive risk management.
Participants will explore the ‘why’ behind global regulatory expectations (FDA, EMA, WHO, and PIC/S), learning how to design and execute robust quality strategies that withstand rigorous inspections, optimise operational efficiency, and, above all, guarantee patient safety.
CPD Hours: 18
Course Content
- Day 1
- The evolving global GMP landscape
- Next-generation quality risk management (QRM)
- Advanced deviation management & root cause analysis (RCA)
- Workshop: risk-based deviation case studies
- Day 2
- Modern data integrity governance
- Computer systems validation (CSV) to software quality assurance (CSA)
- Sterile manufacturing and annex 1 dynamics
- Biotechnology and ATMP Specific GMP Challenges
- Day 3
- Product lifecycle and tech transfer (ICH Q12)
- Supply chain GMP and vendor qualification
- Inspection readiness and handling hostile audit scenarios
- Panel discussion and future pharma (pharma 4.0)
- Wrap-up and evaluation test
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.
