Course overview
This intensive two-day training course will equip you with the essential skills and knowledge needed to effectively plan, manage, and execute internal GMP audits. As part of the pharmaceutical industry’s commitment to producing safe and effective products, Good Manufacturing Practices (GMP) audits are crucial for maintaining compliance with regulatory standards and ensuring product quality. Internal GMP audits play a vital role in identifying potential risks, ensuring manufacturing processes adhere to the highest quality standards, and preparing your organisation for external regulatory inspections.
Whether you’re new to auditing or looking to refine your existing processes, this programme will provide you with the tools needed to conduct thorough audits that assess compliance, identify non-conformities, and drive continuous improvement within your organisation.
By the end of this training, you will be able to confidently manage internal GMP audits, ensuring your company consistently meets regulatory requirements and maintains the highest levels of product quality and safety.
CPD Hours: 12
Course Content
- Day 1
- Introduction to internal GMP audits
- The role of internal audits in compliance and risk management
- Planning for internal GMP audits
- Managing the audit process - best practices
- Workshop - risk management practices in internal audit plan preparation
- Day 2
- Conducting the internal GMP audit
- Documenting audit findings and reporting
- Corrective and preventive actions (CAPA)
- Post-audit follow-up and continuous improvement
- Managing challenging audit scenarios
- Workshop - risks of opening and closing meetings of internal audits
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.
