Part of Audit Essentials: From Interviews to Inspections series:

Led by industry expert Mustafa Edik, this comprehensive new training series is designed for professionals in the pharmaceutical industry who want to master GMP audits. Learn how to conduct thorough audits, manage supplier assessments, and confidently handle regulatory inspections. The courses in this series cover everything from raw material audits and GMP compliance to overcoming challenges and maintaining audit readiness for major health authorities like the FDA, EMA, and WHO. Additionally, you’ll gain crucial knowledge of Good Distribution Practices (GDP) and Good Storage Practices (GSP) to ensure product quality and safety. Ready to elevate your auditing expertise and stay ahead of industry standards? Enrol today!

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.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

Learn questioning techniques used to gather critical insights about processes, responsibilities, and compliance
Improve critical thinking and analytical skills to draw accurate conclusions
Identify deviations from documented procedures
Discuss building a rapport and trust with employees to foster cooperation during audits
Gain a deeper understanding of GMP regulations and how they apply to real-world processes
Combine technical knowledge with interview techniques ensuring the audit process is more comprehensive
Develop interpersonal and soft skills, such as active listening, empathy, and emotional intelligence

Who should attend

This training would suit those in the following departments:

Quality Assurance
Quality Control
GMP Compliance
Auditing
IT
Regulatory Affairs
Engineering
Supply Chain

This course will cover:

The role of interviews in GMP audits

Why interviews are essential for a comprehensive GMP audit
How interviews complement document reviews and observations
Identifying gaps in documented processes through interviews

Interview techniques overview

Types of interviews (structured, semi-structured, unstructured)
Preparing for an interview: setting objectives and expectations
The importance of active listening and asking the right questions

Effective questioning techniques

Open vs. closed questions: when and how to use them
Probing techniques: digging deeper for useful information
Avoiding leading or biased questions
Encouraging honest and detailed responses

Building rapport and trust and observing non-verbal cues

Techniques for creating a comfortable environment for interviewees
The importance of empathy and active listening
Overcoming nervousness or resistance from interviewees
Handling difficult or defensive individuals
Recognising body language and facial expressions during interviews
How to interpret non-verbal cues to assess truthfulness or hesitation
Adapting interview techniques based on observed behaviours

Case study

Participants engage in a group discussion on common GMP audit interview challenges

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.

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