Principles of GLP
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Format: | Electronic Video |
Language: | English |
Published: |
London :
Henry Stewart Talks,
2012.
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Series: | Henry Stewart talks. Biomedical & life sciences collection. Good laboratory practice.
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Subjects: | |
Online Access: | https://hstalks.com/bs/2241/ Series |
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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.