In this Tech Blast episode, Tim Bolus, Compliance Program Manager at Molecular Devices, provides a 15-minute in-depth exploration of the regulatory landscape of drug discovery and development. Tim examines the good lab and manufacturing processes essential to successful drug discovery, development and production.
Get Tim's insight into the field and discover how to best prepare your lab to pass the FDA's regulations and hear some firsthand cautionary tails!
Contents:
Introducing GXP: 00:40-2:20
Why is GLP important in drug development? 2:20-05:55
Why is GMP important in the manufacturing processes late down the line? 05:55-07:15
Examples of GXP going wrong and the ramifications: 07:15-10:30
Solutions to ensure GXP: 10:30-11:40
Aspects of GLP that need improving: 11:40-13:40
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