Training

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Trainings on toxicological or quality aspects

Trainings on toxicological or quality aspects, can be requested by filling in the contact form. Courses typically consist out of a theoretical part and a practical part (e.g. task, exercises or case studies). The content can be adapted based on the customer’s need. Examples of training topics are:

Toxicology

Human health toxicology – 3 days

A. In vivo toxicology studies

Scientific principles and guidelines; toxicokinetics, acute toxicity, skin/eye irritation, skin sensitisation, genotoxicity, repeated dose toxicity, carcinogenicity, reproductive and developmental toxicity; – 1 day

B. In vitro toxicology studies

C. In silico toxicology studies & read-across (non-testing)

Risk assessment – 2 days

Training course can be focused on risk assessment of extractables & leachables (E&L) of container closure systems (PQRI) or of medical devices (ISO-10993-17)

A. Basic principles of risk assessment

Basic principles of toxicology, risk assessment: hazard identification, hazard characterization, exposure assessment, risk characterization

B. Literature data for the hazard assessment

C. Non-testing methods & safety limit calculation

Quality

Module 1: Basic GLP training – 0.5 day

GLP principles: Why/when is GLP needed; GLP guidelines & legislation, GLP definitions, GLP principles.
GLP Documentation: Test facility documents, study documents, QA audit documents, GLP statement, QA statement.
Inspection process: Inspection process government; introduction to the GLP monitorate Belgium, Domains of GLP application (scope), pre-inspection, facility-inspection (incl. study inspections) + follow-up inspections (following years), GLP certificate.

Module 2: Advanced GLP training – 0.5 day

Module 3: GLP installation planning – 2.5 – 3 h