Course overview
Ensuring the quality and compliance of suppliers is crucial to maintaining the safety and efficacy of products in the pharmaceutical industry. Supplier audits play a vital role in this process, as they assess whether material and service providers meet the stringent standards required for pharmaceutical manufacturing.
This training is designed to equip you with the knowledge and practical skills necessary to effectively conduct supplier audits, covering both materials and services. Whether you are responsible for auditing raw material suppliers, contract manufacturers, or service providers such as logistics and packaging suppliers, this programme will provide you with the tools to evaluate their processes, identify potential risks, and ensure compliance with regulatory requirements like Good Manufacturing Practices (GMP) and other industry standards.
By the end of this training, you will be better prepared to manage supplier relationships confidently, ensuring that all materials and services meet the highest industry standards, thereby protecting your company, products, and customers.
CPD Hours: 12
Course Content
- Day 1
- Introduction to supplier audits in the pharmaceutical industry
- Understanding regulatory requirements for supplier audits
- Scope and planning
- Auditing material suppliers - key focus areas
- Workshop - risk based API supplier audit plan and prioritisation rules
- Day 2
- Auditing service providers (logistics, packaging, contract manufacturers)
- Audit execution and on-site techniques
- Identifying non-conformities and corrective actions
- Supplier relationship management and audit follow-up
- Interactive workshop: how and according to which guidelines are audits of service providers carried out
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.
