Regulatory Compliance for Drugs & Biologics
BIOL-40101
Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act. In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.
Course Information
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
All course materials are included unless otherwise stated.
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Instructor: Kadambi Ajit-Simh, M.S.
President, Shiba Biotechnology
K.A. Ajit-Simh established Shiba Biotechnology Inc., in 1999 to provide regulatory compliance / quality strategy and support to the biotechnology, pharmaceutical and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted US FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an Adjunct Professor / Instructor at SDSU in Regulatory Affairs.
