Training & seminars
Practical Stability Study Application to Pharmaceuticals (25 – 26 April 2018) – 2 day Course
22 December 2017
Aim: This course is designed to provide the quality professional with the key requirements for establishing andimplementing a successful stability trial program. It will review the relevant ICH guidance documents and will include workshops to provide practical application of the key requirements for stability. It will develop techniques for planning new and on-going stability trials.
Day 1 AM ► ASEAN stability guidelines
PM ► Preparation of stability protocol
PM ► Bracketing and matrixing designs for new drug substances and products (ICH Q1D)
Day 2 AM ► Evaluation of stability data (ICH Q1E)
PM ► Registration applications in climatic zones III and IV (ICH Q1F)
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PM ► FDA guideline on container/closure integrity |