OUR COURSES

New annex 1: a global perspective

Course Details

Module length  
1 Day/1,5 Days
Learning tools  
Presentations, Lectures, Case Studies, Discussion, Question & Answers session, Final Evaluation Test

 

Target audience  
Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance

Agenda

EU GMP Annex 1 : Reason of revision and revision history, Document map and new approach to Facility & Processes change
Presentation with focus to major change vs. 2009 Annex 1
“Deep Diving” on revised and new chapters with Industry case studies and experiences :

Quality System, Personnel
Premise & Equipment, documentation
Quality Control, Outsourced activities 

Industry Survey , Gap Analysis and Gap Recovery for compliance with the new Annex 1

Regulatory & technical references

  • EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
  • Part I - Basic Requirements for Medicinal Products
  • EU GMP Annex 1 - Manufacture of Sterile Medicinal Products
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