The pharmaceutical industry is tightly regulated, allowing the commercial sale of medicinal products only if regulatory requirements are met. This course emphasizes the US FDA GXPs that apply to managing quality within the pharmaceutical, chemical, and biotechnology industries and touches on differences between the other regional markets in the rest of the world. Students will gain an introduction to Good Practices (or GxPs) including Manufacturing (GMPs), Clinical (GCPs), Laboratory (GLPs), and Automated Manufacturing (GAMPs), and will explore the lifecycle of a drug, from development through to commercial production.
Course Number: BIOL-40353
Credit: 3.00 unit(s)
Related Certificate Programs: Quality Assurance and Control
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6/26/2023 - 8/28/2023
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.
In his current role, Saurabh Kothari is the Director of Regulatory Affairs at Evelo Biosciences. He has a broad cross-functional experience spanning multiple functional areas including regulatory affairs, pharmacovigilance, quality assurance, clinical operations, and lab research, in organizations varying from small to large biotech/pharma companies as well as CROs. Saurabh currently resides in Boston, MA; and holds a Bachelor’s degree in Pharmacy, an MS in Biological Sciences, MS in Regulatory Affairs, an MS in Project Management; and professional certifications including RAC and CCRP.
No refunds after: 7/3/2023.
6/26/2023 - 8/28/2023
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or firstname.lastname@example.org for information about when this course will be offered again.