The Latest Updates in Global GMP (Good Manufacturing Practice) In-house Training

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.

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Format: Live online
CPD: 1.5 hours for your records
Certificate of completion

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Course overview

This webinar will provide the latest GMP updates which are supported by the following health regulatory authorities: EMA, PIC/S, FDA, WHO, ANVISA, MHRA, etc. and will address all sections that will be revised in the GMP Guide. Concept papers, draft articles, and the latest developments in the International GMP Guidelines will also be discussed.

Many pharmaceutical manufacturers tend to describe GMP practices as the rules that personnel must comply with throughout production and the recording of production steps. However, GMP is a comprehensive set of rules in which the steps to be followed in all processes, including the production of pharmaceutical products and R&D activities throughout the product life cycle, are validated and recorded.

GMP disasters throughout history have caused indelible tragedies in many companies. Every country that considers patient health and safety as the priority allows the production, import, and sale of pharmaceutical products per the internationally recognised current GMP rules. GMP, regularly appears as cGMP (current Good Manufacturing Practices) and is encouraged and supported by the regulatory authorities who often remind the manufacturer that they must constantly stay up-to-date.

This webinar will provide an essential update on the latest changes and ensure you are cGMP ready.

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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

Refresh your existing knowledge surrounding GMP practices
Learn the latest updates in cGMP, including guidance from the EMA, PIC/S, FDA, WHO, ANVISA and MHRA
Explore the latest innovations in the concept papers, draft articles and the latest developments in the International GMP Guides

Who should attend

Quality Assurance Personnel
Quality Control Personnel
GMP Compliance Personnel
Manufacturing Personnel
Supply Chain/ Logistics Personnel
Regulatory Affairs Personnel
Engineering Personnel
IT Personnel
Regulatory Authority Inspectors/Auditors (Human and Veterinary Medicinal Products)

This course will cover:

Brief History of GMP
APIC, USP, ICH Updates
PIC/S, FDA, EMA, MHRA, WHO and Other Health Authority Updates
Q&A Session

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 his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.

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