Good Laboratory Practices

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Event Date/Time: Nov 30, 2010 End Date/Time: Dec 01, 2010
Early Registration Date: Oct 10, 2010
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Description

Program Outline
- Various GLP’s: An Overview &Genesis
- Global Harmonization Initiatives: An Overview of the ICH Process
- Good Laboratory Practices Definition and Objectives
- Study Director, PI, QAU, Management, Archivist, Sponsor: Roles and Responsibilities in the GLP’s (FDA/OECD)
- Data Management in a Regulated Environment- Chromatographic Data Systems
- Testing and Report Control
- Hands on Half Day Interactive Workshop: Development of a GLP Study Protocol
- Validation of Analytical Software in a Regulated Environment
- Best Practices for Equipment and Method Verification/Validation
- Developing Validation Policies and Procedures Suitable for GLP Work

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