|Articles|February 15, 2002
- BioPharm International-02-01-2002
- Volume 15
- Issue 2
Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection
Author(s)Barbara Unger
By Barara W. Unger, Don Hill Associates, Inc., pp. 14-18, 71. An effective, well-developed, and versatile preapproval inspection model focuses management and inspectors on conclusions, minimizes process reinvention, and tracks inspection readiness, especially when you are using a contract manufacturer.
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21 CFR Part 11: (Un)Expected Added ValueNewsletter
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