Auditing and Validation Services for FDA Regulated Industry

 

   

 

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Location

1 Day 21 CFR Part 11 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

Part 11 and Systems Validation

  • 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 Audits and Management of Inventories
  • Risk Analysis - How to classify risks
  • Determine Which Systems Need to be Validated and How Much Validation is Required
  • The SaaS Model
  • The 3rd Party Risks
  • Software / System Development Life Cycle (SDLC)
  • Compiling the Validation Master Plan (VMP)
  • Project Plan (PP) Development
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Design Specifications / Design Qualifications (DQ)
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Auditing GxP Computer Systems


 

 

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