21 CFR Part 11: (Un)Expected Added Value

Dillon,Ralph;Noferi,Joseph;Worden,Daniel;

Publication

Article

February 15, 2002

BioPharm International

BioPharm International-02-01-2002

Volume15

Issue 2

Pages: 44-50

21 CFR Part 11: (Un)Expected Added Value

Author(s):

Ralph L. Dillon,Joseph F. Noferi, Esq.

By Joseph F. Noferi, Esq., Ralph Dillon, and Daniel E. Worden, pp. 44-50. Implementing the ERES rule will do more than make your organization compliant with federal regulations. It will strengthen its intellectual property position for the information age.

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Outsourcing Outlook: Reaping the Benefits of E-Procurement

The Immunogenicity of Therapeutic Proteins

Analytical Advances: Calibration Management of Outsourced Calibrations

High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge

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