Hogeschool Leiden

GMP Advanced

Good Manufacturing Practices or GMP is essential in research, development and production of medicines. From manufacturer to hospital, regardless of the size of the company, all must comply with GMP regulations. GMP provides guidance in areas of quality management, training of personnel, method of production and testing, qualification of rooms, facilities and equipment, and validation of processes, test methods, cleaning methods and computerized systems.

This interactive course focuses on new trends and hot topics in GMP, including aseptic processing and environmental monitoring. Inspection findings and case studies are used as teaching examples and will be exercises in self reflection. Risk management will be highlighted as well as human errors.

Keywords: CBD, GMP, GXP, GLP, annex 2 EU GMP, warning letter, BSL-2, risk management, human error, deviation management

During this course you will learn to:

  • understand the principles of the GMP and recognise these principles in your work;
  • understand the most important aspects in annex 1 and 2 of the EU GMP;
  • make a risk assessment by identifying and analysing potential failures during interactive assignments;
  • recognise critical steps in aseptic processing and monitoring and understand measurements in the prevention of cross contamination;
  • understand deviation management and how to use a human error tool.

For whom:
employees in the (bio)pharmaceutical industry with basic knowledge of GMP

Course hours:
9.00 – 17.00 hr

Course date:
will be announced later

Accreditatie is bij de NVML aangevraagd en toegekend (7 UEC)

proof of participation

will be announced later

Course fee
will be announced later

All our courses can be arranged as customized programs. For questions you can contact us by phone 071-5188743 or via cbd@hsleiden.nl

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