Principles of GLP

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Bibliographic Details
Other Authors: Long, David (Speaker)
Format: Electronic Video
Language:English
Published: London : Henry Stewart Talks, 2012.
Series:Henry Stewart talks. Biomedical & life sciences collection. Good laboratory practice.
Subjects:
Online Access:https://hstalks.com/bs/2241/
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Table of Contents:
  • Contents: Where does GLP fit into the R&D model?
  • FDA vision of R&D
  • Successive R&D phases
  • Regulation
  • Good "X" practices
  • Pharmaceutical R&D model
  • R&D spending and success
  • Compliance to GLP
  • Economic, ethical, scientific and regulatory reasons
  • GLP: a quality management system (QMS)
  • GLP as a quality assurance system
  • Planning of scientific studies
  • Study performance
  • Raw data acquisition
  • Study report
  • Archive
  • Monitoring
  • The basics of GLP: a different perspective
  • Documentation
  • Traceability/reconstruction.