Auditing and Validation Services for FDA Regulated Industry

 

   

 

 

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Location

1 Day Laboratory GLP/GMP Boot Camp

All Boot Camps Includes:

  • Travel
  • Hotels
  • Expenses
  • Up to 20 Binders, Handbooks and Certificates*
* Additional copies available for $50.00 each
Day 1 Topics

GLP Training Objectives

  • US FDA 21 CFR Part 58 - Good Laboratory Practice for Non-Clinical Laboratory Studies
  • US FDA 21 CFR Part 211 - Laboratory Controls - In-Process Inspection, Sampling, and Laboratory Control
  • ISO 17025 General requirements for the competence of testing and calibration laboratories - The Basics
  • Title 42: Public Health Part 493—Laboratory Requirements - The Basics
  • OECD Principles of Good Laboratory Practice and Compliance Monitoring Part 1

US FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures

  • 21 CFR Part 11 History
  • 21 CFR Brief Overview
  • Definitions, System Types and Classifications
  • The Systems and Software Types
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • 21 CFR Part 11 a) - k) Requirements
  • Setting up the Steering Committee and Charter
  • Conducting the Inventories
  • Risk Analysis - How to classify risks
  • Determine Which Systems Need to be Validated

 

 

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