1-Day Training Curriculum
Good Laboratory Practice Training Objectives
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The 11 General Orders of GMP
- Writing Procedures
- Following Procedures
- Good Documentation Practice
- Validation
- Design/Build Facilities
- Maintain Facilities
- Training, Education and Experiance
- Sanitation and Housekeeping
- Control for Quality
- Audit for Compliance
- Prepare for Battle - Recall/Traceability -
US FDA 21 CFR Part 58 - Good Laboratory Practice
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US FDA 21 CFR Part 211 - Laboratory Controls - QC obligations, In-Process Inspection, and Sampling
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Stabilities (General stability principles)
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OECD Principles of Good Laboratory Practice and Compliance Monitoring Series 1 - The basics
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Validation and Verification (The basics pertaining to systems, software, cleaning and methods)
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ICH Guidelines for GLP (Discusses various applicable ICH guidance)
US FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
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21 CFR Part 11 History and Overview
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21 CFR Part 11 a) - k) Requirements