GxP Trainings

GxP Trainings

Together we can compile courses about the hows and whys of working under GMP and GLP. The differences between GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) - with GxP – are clearly explained.

Training offer

You may compile a programme from the following on offer:

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 (Good Documentation Practice)
  • 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

A'GAMP training

GAMP5© was introduced at the beginning of 2008 ; whereby a risk-based approach is appropriate for automated systems. Our Agidens project methodology is based on the principles described in GAMP5©. This A'GAMP methodology has proven itself over the years in several successfully implemented projects. We, therefore, like to share our knowledge with GxP companies and ISO 17025 or ISO 15189 certified laboratories through, for instance, computer validation training.

FMEA training

With our wealth of experience in the execution and coordination of risk analyses we developed a training course about the execution of an FMEA (Failure Mode and Effect Analysis). The course consists of a theoretical part and a workshop with examples from practice.

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