Validation principles methodology and documentation

Module Lenght

from 1 day and a half to 2 days

Agenda

  • Regulatory aspect from International Agencies
  • Technical Background
  • Validation Life Cycle
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Calibration
    • Performance Qualification

Target audience

  • Engineering
  • Validation
  • Maintenance
  • Manufacturing

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final Evaluation Test

Regulatory & technical references

  • EU-GMP Annex 15 “Qualification and Validation”
  • WHO TRS 937, Annex 4 “Supplementary guidelines on Good Manufacturing Practices: Validation”
  • PIC/S PI 006-3 “Validation Master Plan – Installation and Operational Qualification – Non-Sterile Process Validation – Cleaning Validation”
  • PIC/S PI 007-6 “Recommendation On The Validation Of Aseptic Processes”
  • ISPE Good Practice Guide “Applied Risk Management for Commissioning & Qualification”
  • ASTM E2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”

Number of trainers

One

Tailoring option available

No

Final evaluation quiz

Yes

Contact

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