Stability Testing in the Pharmaceutical Industry

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The agenda proposal aside 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.

Agenda Proposal

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

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