Course overview
In the highly regulated pharmaceutical and life sciences industries, patient safety and product efficacy depend entirely on the integrity of the manufacturing and supply chain processes. Compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) is not merely a legal checkbox; it is a critical operational standard that safeguards global health.
This comprehensive, three-day master class is designed to transform industry professionals into elite, forward-thinking auditors. Delivered by expert trainer, Mustafa Edik, this course bridges the gap between theoretical regulatory text and hard-hitting, real-world inspection strategies.
The landscape of pharmaceutical regulation is evolving at a breakneck pace. With the recent, stringent overhauls of EU/PIC/S GMP Annex 1 (Sterile Manufacturing), the global push toward automated technologies under Annex 11, and the heightened scrutiny on Data Integrity (DI), standard auditing checklists are no longer sufficient.
Furthermore, international cross-border supply chains have become incredibly complex. Moving a product from raw Active Pharmaceutical Ingredients (APIs) to the patient’s bedside requires flawless oversight of contract manufacturers, third-party logistics (3PL) providers, and multi-modal cold chain transportation networks. This course equips you with the strategic mindset and tactical tools required to identify vulnerabilities before regulatory authorities do.
This master class is meticulously structured around four critical dimensions of pharmaceutical quality oversight:
- Global Regulatory Harmonization: Mastery over the overlapping and distinct requirements of major health authorities, including the FDA (USA), EMA / EU GMP, TİTCK (Turkey), and PIC/S frameworks. You will learn to navigate ICH guidelines
- Risk Management
- Quality Systems
- Analytical Procedure Development, and
- Stability
- The Auditor Mindset: Shifting from a ‘policeman’ auditing style to a constructive, risk-based investigator. You will learn how to build an objective audit scope, manage team dynamics, and handle high-pressure scenarios, such as opening/closing meetings and challenging corporate cultures.
- Specialised Technical Competence: Moving beyond basic warehouse and facility walkthroughs. You will deep-dive into advanced technical auditing, including qualifying API/excipient suppliers, validating complex computerised systems, and inspecting high-tech biotechnology facilities (e.g., mRNA vaccine lines, Monoclonal Antibodies (mAbs), and blood products).
- Defensive CAPA & Crisis Management: Understanding how to respond to critical non-conformances, FDA Form 483s, or official warning letters. You will learn the mechanics of bulletproof Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) tracking to satisfy international inspectors.
CPD Hours: 18
Course Content
- Day 1
- Introduction to quality systems
- Quality management models and global regulations
- Pharmaceutical QMS and GMP synergy
- What is a GMP Audit?
- The strategic necessity of auditing
- Wrap-up and evaluation
- Day 2
- Roles, responsibilities, and audit preparation
- Audit requirements and laboratory control
- Audit execution and post-audit action items
- Supplier auditing - APIs and excipients
- Supplier auditing - packaging materials
- Wrap-up and evaluation
- Day 3
- Computerised systems and data integrity (DI)
- Deep dive into GDP and supply chain validations
- Special technical module: sterility and contamination control (EU/PIC/S Annex 1)
- High-tech and biotech facility inspections
- Future outlook: The next 5 years of GMP/GDP regulations
- Final masterclass evaluation
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.
