Curriculum
- 3 Sections
- 12 Lessons
- 10 Weeks
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- Day One5
- 1.11.2 Introduction to Stability – Abisola Ayodele
- 1.1Stability Testing: Photostability Testing of New Drug Substances and Products – Joseph McCulloh
- 1.21.3 Stability Testing of New Drug Substances and Products Q1A(R2) – Arit Onwisah
- 1.31.4 Stability Testing for New Dosage Form – Abisola Ayodele
- 1.41.5 Evaluation of Stability Data – Ken Miller
- Day Two5
- 2.12.1 Quality of Biotechnology Product: Stability Testing of Biotechnology/Biological Products – Ken Miller
- 2.22.2 Science and Risk-Based Approaches – Product Knowledge to Specification: to utilize stability data to build production knowledge, inform primary and ongoing stability program design and set specifications – Joseph McCulloh
- 2.32.3 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Relationship to Stability)– Roydon Mesquita
- 2.42.4 WHO Technical Report Series 1010 Annex 10 – Jared Auclair
- 2.52.5 In-use Stability Study – Ken Miller
- Day Three2