Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.  

After 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.

 

  • Recorded webcast

New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers

Free

Recorded webcast

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

  • 1.5 CPD hours High impact
  • Presented by Mustafa Edik
  • Next: 5-6 Jun 2024 Live online
  • Also: 15-16 Oct 2024 Live online

Process Validation for Medical Devices

New for 2024

Live online

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 2-4 Jul 2024 Live online
  • Also: 26-28 Nov 2024 Live online

New EU GMP Annex 1: Compliant Aseptic Operations

New for 2024

Live online

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours
  • Presented by Mustafa Edik
  • Next: 9 Jul 2024 Live online

The Latest Updates in Good Manufacturing Practices (GMP)

Free + recorded

Live online

In this free 90-minute webinar, you will gain an insight into the latest updates in GMP, as well as consolidating your existing knowledge on the subject.

  • 1.5 CPD hours Intensive
  • Presented by Mustafa Edik
  • Next: 15-16 Jul 2024 Live online
  • Also: 27-28 Nov 2024 Live online
  • Also: 27-28 Mar 2025 Live online

Best Practices for Supplier Qualification in Life Science

New for 2024

Live online

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 17-18 Jul 2024 Live online
  • Also: 19-22 Nov 2024 Live online

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2024

Live online

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik
  • Next: 22-23 Jul 2024 Live online
  • Also: 14-15 Nov 2024 Live online
  • Also: 17-18 Mar 2025 Live online

Good Distribution Practices of Pharmaceuticals and APIs

New for 2024

Live online

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 24-25 Jul 2024 Live online
  • Also: 16-17 Oct 2024 Live online

Data Integrity Auditor Master Class

New for 2024

Live online

During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik