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In-house Training Programme

  
 

Deviation, Failure Investigation, Annual Product Review and Change Management

  
     
 
When What
8.00 - 8.30 Welcome, Introduction, Presentation of the Speaker
8.30 - 9.30 Regulatory Requirements 
  • Europe 
  • USA
9.30 - 10.30 Out of Specification, OOS 
  • The Barr Case 
  • OOS Failures 
  • Treatment of OOS
10.30 - 10.45  Break 
10.45 - 11.45 Deviation and Changes 
  • Differences between deviations and changes 
  • Occurrence of deviations and changes 
  • Treatment of deviations and changes
11.45 - 12.45 Root Cause Analysis 
  • Treatment and carry out 
  • Involvement of other departments
12.45 - 13.45  Lunch 
13.45 - 14.45 Assessment of Deviation and Changes 
  • Risk analysis 
  • Outcome of the assessment 
  • Relation to other products
14.45 - 15.00  Break 
15.00 - 16.00 Trending/Annual Product Review 
  • Assessment and trending of changes and deviations 
  • Preparing for a report 
  • Content of the report
16.00 - 17.00 Change Management System 
  • Quality management system 
  • SOPs 
  • Involvement of contract manufacturer
17.00 - 17.30 Discussion
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.