OUR COURSES

Validation life cycle (from DQ to PV) approached as per CGMP annex 15

Course Details

Module length  
from 1 day and a half to 2 days
Learning tools  
Presentations, Lectures, Case Studies 
Discussion, Question & Answers session, Final Evaluation Test

 

Target audience  
Engineering, Validation, Maintenance, Manufacturing

Agenda

Regulatory aspect from International Agencies
Technical Background from cGEP (Good Engineering Procedures)
Validation Life Cycle
  • Design Qualification
  • Installation Qualification
  • Operational Qualification
  • Calibration
  • Performance Qualification

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”
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