Tailor-made GxP trainings
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
- Why and where do we need them?
- Who draws up the guidelines and who should follow them?
Principles, requirements, organisation, laboratories, production, cleanrooms, differences between the EU and the US.
How should you document and store all operations in line with regulations?
- 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
GAMP training
Since the introduction of GAMP5© 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.
How can we help?
Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.