Course overview
Ensuring compliance with Good Manufacturing Practices (GMP) is crucial for the safety and effectiveness of products, particularly in the pharmaceutical industry. A GMP audit plays a key role in verifying that these standards are being met, and interviews are one of the most effective tools auditors can use. They provide auditors with the opportunity to uncover operational insights, assess individual performance, and ensure that companies adhere to GMP requirements on a deeper level than just reviewing documents.
While audits generally rely on methods like observing operations, examining records, and reviewing documentation, interviews add an extra layer of depth. Each auditor may have a different style, with some preferring to engage directly with employees, while others focus on paperwork. However, for a GMP audit to be comprehensive, it is essential to integrate interviews, observations, document reviews, and record checks to create a full understanding of GMP compliance.
Interviews are particularly valuable because they allow auditors to understand the practical realities of manufacturing beyond what’s written in manuals. Discrepancies between documented procedures and actual practices may arise, and employees may reveal informal methods that deviate from the standard. With this training, you will learn how to identify these inconsistencies during interviews, empowering you, as the auditor, to make informed recommendations and ensure GMP standards are fully adhered to.
CPD Hours: 6
Course Content
- Day 1
- The role of interviews in GMP audits
- Interview techniques overview
- Effective questioning techniques
- Building rapport and trust and observing non-verbal cues
- Case study
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.
