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.

Objectives
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
Program GMP basic

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
Lecturers:

  • 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
12th and 13th of December 2016

Course hours
9.30 - 17.00h

Extent
16 hours of theory

Certificate
Proof of participation

Registration
Registration is possible until 31st of October 2016. You can registrate here.

Course fee
€ 535,- (there are no early booking discount or rebate possible for this course)

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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