Articles by Paul W. Allen - BioPharm International

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Articles by Paul W. Allen

Responding to Observations

Nov 1, 2003

You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observations. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave ó from developing a corrective action plan to writing a detailed response document.

To Prepare or Not To Prepare - There is No Question

Nov 1, 2003

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.

Conducting the Audit - Ready or Not, Here They Come

Nov 1, 2003

When an FDA inspection is imminent, it pays to have a plan. Start by getting your paper 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 donít forget to take notes.

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