In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|October 15, 2002
- BioPharm International-10-01-2002
- Volume 15
- Issue 10
Survival Guide to FDA Inspections: Part 2, Conducting the Audit ? Ready or Not, Here They Come
Author(s)Massoud Lavian, Paul W. Allen
by Massoud Lavian and Paul W. Allen, Clarkston Consulting When an FDA inspection is imminent, it pays to have a plan. Start by getting your papers in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don't forget to take notes.
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Process Validation: How Much to Do and When to Do Itabout 24 years ago
Biotech Will Recover!about 24 years ago
GMPs and Pharmaceutical Labelingabout 24 years ago
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