OUR COURSES

Batch record

Course Details

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

 

Target audience  
Manufacturing, Quality Assurance, Quality Control

Agenda

Master Batch Record implementation
Data entry rules
Procedure to be followed
Revision of Batch Record
Primary packaging
Secondary packaging

Regulatory & technical references

  • EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
  • Annex 16 Certification by a Qualified Person and Batch release
  • PIC/S (PE 009-16) Certification by Authorised Person and Batch Release
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