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
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Course Provider
Mustafa Edik,
Independent GMP Consultant and AuditorAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
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
