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In-house Training Programme

 
 

Stability Testing  in the Pharmaceutical Industry

 
     
 
When What
Day 1  
09.00 - 09.45 h Overview of Stability Testing
09.45 - 10.00 h Discussion
10.00 - 10.45 h The ICH and other Guidelines
10.45 - 11.00 h Discussion
11.00 - 11.30 h Break
11.30 - 12.15 h Stability Testing for Drug Substances and Stress Testing
12.15 - 12.30 h Discussion
12.30 - 14.00 h Lunch
14.00 - 14.45 h Stability Testing for Drug Products
14.45 - 15.00 h Discussion
15.00 - 15.45 h Stability Plans & Protocols
15.45 - 16.00 h Discussion
16.00 - 16.30 h Break
16.30 - 17.15 h Validated Analytical Methods and Procedures
17.15 - 17.30 h Discussion
   
Day 2  
08.30 - 09.15 h Stability Testing for Existing Products and Line Extensions
09.15 - 10.00 h Bracketing and Matrixing for Reduced Stability Testing
10.15 - 10.30 h Discussion
10.30 - 11.00 h Break
11.00 - 11.45 h Evaluation of Stability Results - Statistical Considerations
11.45 - 12.00 h Discussion 
12.00 - 12.30 h Evaluation of Stability Results, Shelf Life Prediction
12.30 - 12.45 h Discussion
12.45 - 14.00 h Lunch
14.00 - 14.45 h Outsourcing of Stability Testing to Contract Laboratories
14.45 - 15.00 h Discussion
15.00 - 15.45 h Report Formats CTD and Major Authority requirements 
15.45 - 16.00 h Discussion
16.00 - 16.30 h Break 
16.30 - 17.00 h Panel Discussion (Collected Questions)
 
 
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.

 

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