Event Information

Event Topic:
The pivotal role of CMC in the drug approval process

Event Description:
Solid state chemistry, polymorphic forms of the drug and the ability to scale up manufacturing are very important details that define the identity as well as feasibility of a drug. Very minor changes in any or each of these aspects of the drug can pivot chances of scale up, or a process to launch or acquire approval. Things change on the brink of scale up and manufacturing for commercialization to almost derail approval and this talk will feature case studies in this area.

Date/Time:
Date(s) - 07/13/21
6:30 pm - 8:30 pm

Event Location:
Zoom talk: https://us02web.zoom.us/j/88274227563:

Speaker Information

Event Speaker:
Chitra Sharma

Event Speaker Title:
Founder & CEO

Event Speaker Company:
gCompliance, Inc.

Event Speaker Bio:

Chitra Sharma has over 15 years of experience in pharmaceutical development of small and large molecules. In 2011, Chitra founded gCompliance, Inc., with a vision to execute turnkey projects in pharmaceutical development to commercialization. gCompliance, Inc engages in early phase tiered development processes and takes them to launch. Her consulting firm has strong collaborations with industry resources. gCompliance, Inc takes on processes to scale up, meet optimization needs with quality and regulatory compliance built into the design. There is a concerted effort to strengthen internal resources and product specific requirements to build robust product portfolios for client organizations. gCompliance, Inc. has clients ranging from virtual biotech to large pharmaceutical firms, globally. Chitra previously worked at Vivus, Genentech, Cor Therapeutics, Roche BioSciences and Boehringer Ingelheim. She holds a MS in Pharmaceutical Sciences from the University of Connecticut, Storrs, CT.

Event Details

Cost:
$0

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