Tailor-made GxP trainings

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Tailor-made GxP trainings

As expert in the Life Sciences industry, we offer several trainings in the field of GxP. Together we can compile courses about the hows and whys of working under Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). The differences between GMP and GLP are clearly explained by our consultants.

Tailor-made GxP trainings

GxP legislation and guidelines
  • Why and where do we need them?
  • Who draws up the guidelines and who should follow them?
GMP/GLP

Principles, requirements, organisation, laboratories, production, cleanrooms, differences between the EU and the US.

GDP

How should you document and store all operations in line with regulations?

GMP/GLP in the laboratory
  • Personnel: training, hygiene, laboratory
  • Documentation: raw data, documents, log books, procedures, reporting, storage and retention (data and standards)
  • Instrumentation: calibration, qualification, computerised systems
  • Analytical methods and validations (pharmacopoeias and in-house methods): materials and reagents, specifications and out-of-specifications (OOS), change of control
  • Stability studies: requirements, protocols, climate zones, simulation
  • External and internal audits: what, why and how, preparation, consequences

Other trainings

How can we help?

Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.

 

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