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DEVELOPING QUALITY AWARENESS COURSES FOR GOOD MANUFACTURING PRACTICE (cGMP), GOOD LABORATORY PRACTICE(cGLP) AND ISO 17025 LABORATORIES

Whether your laboratory operates in a regulated (cGMP,cGLP) or an accredited (ISO 17025) environment, you will need to ensure that your staff are trained and fully comprehend their responsibilities to produce accurate, precise, reliable and trustworthy results; together with a full understanding of the potential consequences of any failure to meet the required standards. In addition it is also critical that the training your staff receive is consistent for all staff, irrespective of when they joined the laboratory. The traditional class room lesson training format can present a number of problems:


One way of addressing these problems and achieving consistent, cost effective training is to use computer based training techniques based on PowerPoint ™ presentations, with a voice over narrative. This ensures all members of staff who study the same course receive the same training information.

We can develop training courses, which can be adapted to your laboratory’s specific requirements, covering the following topics:


  1. Introduction to current Good Laboratory Practice (History of cGLP, cGLP regulations and ISO 17025 requirements, Consequence of non-compliance)
  2. Laboratory Quality Management Systems
  3. Organisation, Roles and Infrastructure in a Regulated or Accredited Laboratory
  4. Performing Analysis in a Regulated or Accredited Laboratory
  5. Laboratory Data Integrity
  6. Conducting laboratory Investigations
  7. Laboratory Audits
  8. Use of Computers in the Laboratory, Annexe 11 and 21 CFR Part 11