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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