Hogeschool Leiden

Basic Principles of GMP (English course)

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 process validation, analysis, cleaning and computers.

This course briefly discusses all aspects mentioned and their role in the overall process. Also, it describes changes within the company and the way these affect the quality system.

Keywords: CBD, GMP, GXP, GLP, quality system, pharmacopoeia.

During this course you will learn to:

  • know the laws and procedures according to which you need to work;
  • understand the meaning of these laws and procedures;
  • recognize mistakes made in protocols during interactive assignments;
  • recognize mistakes made during development and production of drugs in articles, that will be extensively studied during groupassignments;
  • understand the aims and importance of a quality system, how to develop it and when it needs to be adjusted.

Program GMP basic ( pdf, 146 KB )

For whom?
Employees in the (bio) pharmaceutical industry. This basic course is also intended for individuals who do not directly contribute to the (bio) pharmaceutical processes.

Course information

  • Mrs. H. Nelis, Managing Consultant, Xendo
  • Mr. drs. S. Meulenbelt, QA Manager, Xendo
  • Mr. dr. N.M. Stapleton, Site Director MicroSafe Laboratories/Mr. dr. M. Rijnbeek, Microsafe Laboratories
  • Mrs. dr. J.S. de Koning-Ramaker, J. de Koning Consultancy

Course dates
29th and 30th May 2017

Course hours
9.30 - 17.00h

16 hours of theory (12 UEC)

Proof of participation

Registration is possible until 17th of April 2017. You can registrate here

Course fee
€ 845,- (Registration before 23 December 2016 € 770,-)  (No extra costs of VAT)

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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