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SELECTBIO Conferences QbD in Pharma Development World Congress

Sushil Srivastava's Biography



Sushil Srivastava, Process Research and Development Director, Bristol-Myers Squibb

Dr. Sushil K. Srivastava is the Director of Chemical Development (Drug Substance), Pharmaceutical Development at Bristol-Myers Squibb (BMS). He is responsible for late phase development including QbD/PAT, technology transfer of drug substance processes to commercial manufacturing sites and providing source documents for CMC filings and responses to Health Authority questions. He received his Ph.D. degree in synthetic organic chemistry from Banaras Hindu University, Varanasi, India in 1978 and had post doctoral experience in physical organic chemistry with Prof. W. J. le Noble, State University of New York, Stony Brook, NY and E. C. Ashby, Georgia Tech at Atlanta, GA prior to joining BMS in 1987.

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Development of Scientifically Sound Control Strategy for Drug Substance

Thursday, 16 April 2015 at 11:45

Add to Calendar ▼2015-04-16 11:45:002015-04-16 12:45:00Europe/LondonDevelopment of Scientifically Sound Control Strategy for Drug SubstanceQbD in Pharma Development World Congress in ChandigarhChandigarhSELECTBIOenquiries@selectbiosciences.com

In this talk risk based approach will be discussed for efficient development of the DS control strategy. This talk will cover the following points: Identification of Critical Quality Attributes of the drug substance,Understanding of formation and purge of the impurities, Identification and control limits of parameters impacting quality, Setting up appropriate specifications for SMs and intermediates to ensure quality,Verification of control strategy, Defining the scientifically sound control strategy.


Add to Calendar ▼2015-04-16 00:00:002015-04-18 00:00:00Europe/LondonQbD in Pharma Development World CongressQbD in Pharma Development World Congress in ChandigarhChandigarhSELECTBIOenquiries@selectbiosciences.com