Good Manufacturing Practice (GMP) Basic

Good Manufacturing Practices (GMP) Basic Course

Good Manufacturing Practice, or GMP, is the foundation of quality systems in the life sciences. GMP courses have traditionally been taught with a top-down, slide-deck lecture approach – in which participants are drowned in regulatory jargon before ever understanding why these systems are necessary and how they work together.

This course is different.

You’ll work together with your instructor, Torben Elhauge, to build a theoretical pharma/biotech company (Company X) from the ground up. Through interactive discussion and activities, you’ll decide what needs to be in place to produce a product that has sufficient quality to be safe and effective for patients. This includes the demands on management, employees, suppliers, facilities, raw materials, equipment, quality control, etc.

These discussions will be weaved with historical anecdotes and practical examples from Torben’s over 20 years of experience in the pharma industry. Once the class has collaborated to decide on the demands necessary for Company X, you’ll compare your work to existing regulatory requirements (fx. EU legislation - Eudralex vol. 4).

This teaching methodology means you won’t just go home with a summary of EU legislation you could have found online. Instead, you’ll leave with a clear understanding of the purpose of existing regulatory requirements and the critical thinking skills required to put GMP concepts into practice in your daily work.


About the Instructor

Torben Elhauge has more than 25 years’ experience in GMP regulated areas and holds a master’s degree in chemical engineering. He has broad experience within all parts of the CMC area – from development over validation and registration to GMP release of products. He has in-depth knowledge of the regulatory landscape and worked at the Danish Medicines Agency for more than 6 years. He has also worked within the QA area, conducting GMP training and audits. He has extensive training experience lecturing for the MIND at KU, Pharmakon, Lægemiddelstyrelsen, as well as internal GMP related courses for several Pharma IT customers. 
 

Participants will leave this course having:

• Understood GMP pharmaceutical quality systems and key terms used therein
• Learned common concepts and methods of qualification and validation
• Gained the ability to find and describe relevant regulatory requirements concerning personnel, premise, equipment, documentation, and production
• Recognized how GMP Course concepts appear in the daily work of life science professionals

Who should participate? Any current or future life sciences professional, looking to build a strong GMP foundation. No prior knowledge is required.

Logistics: The course is held in person and the duration is two days, from 9 AM to 4 PM. The course will be held in person at Pharma IT's office in Copenhagen (Skelbækgade 2, 1717 København).

Your purchase includes:

• Meeting materials
• Breakfast, lunch & afternoon snack
• Certificate of course completion
• 1-year free membership to the Pharma IT Network

Are you currently unemployed and wish to attend this course, then click here for more information!