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GLP Training

Supporting Clinical (GCLP or GMP)

1-Day Curriculum

2-Day Curriculum Includes OECD

Good Laboratory Practice Training Objectives

  • The 11 General Orders of GMP
    - Writing Procedures
    - Following Procedures
    - Good Documentation Practice - Logbook Management,
        Records and Data 
    Integrity
    - Validation - Software - Equipment
    - Design/Build Facilities - Laboratories
    - Maintain Facilities - Maintenance, Metrology, and Engineering
    - Training, Education and Experience
    - Sanitation and Housekeeping, Pest Control, and Waste Management
    - Control for Quality
    - Audit for Compliance
    - Prepare for Battle - Recall/Traceability Audits

  • US FDA 21 CFR Part 58 - Good Laboratory Practice

  • US FDA 21 CFR Part 211 - Laboratory Controls - QC obligations, In-Process Inspection, and Sampling

  • Stabilities (General stability principles)

  • Validation and Verification (The basics pertaining to systems, software, cleaning and methods)

  • ICH Guidelines for GLP (Discusses various applicable ICH guidance)

 

US FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures - Software, Spreadsheets and LIMs

  • 21 CFR Part 11 History and Overview

  • 21 CFR Part 11 a) - k) Requirements

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