Articles by Nancy Cafmeyer - Pharmaceutical Technology

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Articles by Nancy Cafmeyer

Nancy Cafmeyer


http://www.abcforfda.com

Nancy Cafmeyer is a consultant at Advanced Biomedical Consulting (ABC), LLC, with over 28 years industry experience has consulted at numerous pharmaceutical, nutritional supplement, and medical device manufacturers and prior to working for ABC has held both hand-on and management positions at companies such as King Pharmaceutical, Geopharma, and Daniels Pharmaceuticals. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522.

Articles
How to Effectively Manage a Product Recall
January 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
October 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
September 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
April 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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