Articles by Jonathan M. Lewis - Pharmaceutical Technology

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Articles by Jonathan M. Lewis

Jonathan M. Lewis

Jonathan M. Lewis, a principal at Advanced Biomedical Consulting (ABC), LLC, has consulted at over 50 different biopharmaceutical, pharmaceutical, and medical device manufacturers and prior to starting ABC has held both hand-on and management positions at companies such as Cardinal Health, KMI, and PAREXEL International. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522

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 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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