RSS Newsfeed  Your shopping cart.
ECA Academy - Your GMP/GDP Information Source

Search in



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.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.


 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Medical Devices
 GMP Basic Training Courses