|Articles|February 15, 2002

BioPharm International

  • BioPharm International-02-01-2002
  • Volume 15
  • Issue 2

21 CFR Part 11: (Un)Expected Added Value

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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Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection

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Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar

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Outsourcing Outlook: Reaping the Benefits of E-Procurement

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The Immunogenicity of Therapeutic Proteins

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Analytical Advances: Calibration Management of Outsourced Calibrations

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High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge

almost 24 years ago

Inside Washington: Costs and Controls Challenge Manufacturers

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