|Articles|October 15, 2002

BioPharm International

  • 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

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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FDA Launches Major CGMP Review

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Virus Inactivation in the 1990s ? and into the 21st Century: Part 3b, Plasma and Plasma Products (Treatments Other than Heat or Solvent/Detergent)

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Process Validation: How Much to Do and When to Do It

over 23 years ago

Biotech Will Recover!

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Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

over 23 years ago

GMPs and Pharmaceutical Labeling

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Revolutionizing Biologics Regulation

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