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Practical Stability Study Application to Pharmaceuticals (5 – 7 October 2015)
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Aim: This subject is designed to provide the quality professional with the key requirements for 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 ongoing stability trials. Organised by Malaysian Organisation of Pharmaceutical Industry (MOPI) together with Seer Pharma and National Pharmaceutical Control Bureau (NPCB). Date: 5 – 7 th October 2015

Day 1

AM ►Stability testing of new drug substances and products (ICH Q1A)

PM ►Stability testing of new dosage forms (ICH Q1B)

Day 2

AM ►Bracketing and matrixing designs for new drug substances and products (ICH Q1D)

PM ►Evaluation of stability data (ICH Q1E)

Day 3

AM ►Registration applications in climatic zones III and IV (ICH Q1F)

PM ►FDA guideline on container/closure integrity



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