Course overview
Conduct thorough supplier qualifications and audits to strengthen the quality systems of your pharmaceutical, biotechnology, and medical device manufacturing processes.
Ensuring suppliers consistently meet quality requirements is paramount across all materials and services procured. Regulatory agencies such as FDA, EMA, MHRA, TGA, PIC/S, and ISO 13485 have intensified their focus on supplier qualification. The 2015 update of the EU GMP Guide notably emphasised supplier selection and qualification in Chapter 5, marking a significant regulatory shift.
While supplier qualification may have been unfamiliar decades ago, it has now become integral to industry practices. Qualifying suppliers, especially those in regions like China and India, presents unique challenges, demanding additional responsibilities for both parties. Beyond audits, establishing effective "Quality Agreements" is essential. Prior to outsourcing, companies must define minimum product specification and user requirements to ensure compliance with GMP standards. Each product may necessitate specific evaluation criteria during initial technical visits to potential supplier, involving assessment of SOPs, Quality Management Systems, previous audits, organisational structure, and task distribution.
This course equips participants with practical strategies to navigate complex supplier qualification processes, enhancing compliance, and optimizing quality management systems to meet stringent regulatory expectations. Delegates will gain comprehensive strategies and insights into conducting rigorous supplier qualification and audits to enhance the quality systems across pharmaceutical, biotechnology, and medical device manufacturing processes.
Bonus documents included:
- Supplier qualification questionaries (API, excipient, packaging material)
- Supplier evaluation matrix
- Risk-based supplier audits
- Quality Agreement
- Supplier qualification sample SOP
- FDA inspection findings, example warning letters, Form 483s
- Warehouse, logistics service provider qualification documents
CPD Hours: 12
Course Content
- Day 1
- Supplier Qualification Introduction
- Quality Management System and supplier qualification
- Sampling and test reduction
- Raw materials and service providers
- Medical device suppliers
- Flow of supplier qualification & documentation
- Group exercise: Review of an existing supplier categorisation and evaluation study
- Workshop: Supplier categorisation & evaluation
- Day 2
- Supplier auditing
- Quality agreement preparation
- Supply chain risk management
- Group exercise: Review of an existing supplier Quality Agreement
- Workshop: Supplier Quality Agreement
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.
