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Dietary Supplements

$4,995.00  Includes:

  • 10 Handbooks

  • 10 Workbook Binder

  • 10 Certificates for each Attendee

  • Additional sets available for $50.00 ea.

1-Day Training Curriculum

Good Laboratory Practice Training Objectives

  • 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

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

  • Stabilities (General stability principles)

  • OECD Principles of Good Laboratory Practice and Compliance Monitoring Series 1 - The basics

  • 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

  • 21 CFR Part 11 History and Overview

  • 21 CFR Part 11 a) - k) Requirements

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