GIVIMP and GCCP for scientists

Course description

This course goes through the basics of the guidance documents Good in Vitro Method Practices (GIVIMP) and Good Cell Culture Practices (GCCP). The aim of both GIVIMP and GCCP is to reduce the uncertainties in cell and tissue-based work by applying all necessary good scientific, technical and quality practices. This yields better reproducibility and increases the credibility of the results. The course will also go through the necessary steps from in vitro method development to in vitro method implementation for regulatory use in safety assessments (focus on Europe). The course will touch upon the quality management system Good laboratory practice (GLP), but this is not the main focus of the course.

Course outline/outline

  • Overview of the OECD GIVIMP document (No 286)
  • GLP- and regulatory lingo – terminology necessary to understand
  • Good Cell Culture Practices:
    • Primary cells vs cell lines
    • Procedures for cell banking, quarantinization, contamination control, subcultivation, storage and freezing of cells, monitoring of cell performance, cell identity
    • Reporting of cell-based work
  • Handling of raw data
  • SOP handling
  • Facilities, design, risk classes and formal requirements (e.g. regarding working environment)
  • Equipment – calibration, maintenance, etc – how do others do and what need to be done?
  • Animal-free in vitro work (alternatives to serum etc)
  • In vitro test method development:
    • In-house validation of in vitro test methods. Ways to keep track of performance (Control charts)
    • Controls and acceptance criteria
    • Equipment set-up and validation of measurement end points
    • SOP development
  • The road from in vitro method development to regulatory acceptance with a focus on the European regulatory landscape.

Who should attend:

Researchers working with cells and tissues, lab managers, scientific leaders and in vitro test method developers, or anyone who is interested in reducing the uncertainties and increasing the robustness and quality of in vitro work. The course is also useful for regulators wanting to understand the specific challenges related to in vitro test methods.

Prerequisites

Basic scientific understanding in the life science disciplines and an interest in good in vitro science

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Date & Time
IndustryCombination products, Medical Device, Pharmaceuticals
LanguageEnglish
LevelBasic
LocationOnline
RegionGlobal

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In-House Training

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Emma Pedersen

Emma Pedersen

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