Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

Lavian,Massoud;Allen,Paul;

Publication

Article

August 15, 2002

BioPharm International

BioPharm International-08-01-2002

Volume15

Issue 8

Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

Author(s):

Massoud Lavian,Paul W. Allen

by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.

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Articles in this issue

Guest Editorial: Quality Agreements with Contract Laboratories

Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

Virus Inactivation in the 1990s ? and into the 21st Century: Part 2, Red Blood Cells and Platelets

Making Regulatory Compliance a Core Process: Director and Officer Liability Exposure

Inside Washington: User Fee Program Seeks to Spur Biotech Development

Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issue

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