Articles by Nancy Cafmeyer - Pharmaceutical Technology

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Articles by Nancy Cafmeyer

How to Effectively Manage a Product Recall

The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.
Jan 2, 2011

The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.

How to Develop a Practical (and Compliant) Vendor Qualification Program

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.
Oct 2, 2009

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment Qualification

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.
Sep 2, 2008

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

Running a Marathon in Flip-Flops – Part 1: The Value of Incorporating Prerequisites into Process Validation

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes.
Apr 2, 2008

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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