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2009 Validation Week IVT Awards Presentation

The Institute of Validation Technology held its annual Validation Week conference in Philadelphia, PA in October 2009. Awards were presented to the winners of the Journal of GXP Compliance “Article of the Year” as well as the “Kenneth G. Chapman” award for outstanding achievement in the field of validation.

And the winners are...

2009 Article of the Year
Winner: “The Role of Critical Review in the Revision of Procedures”
Author: Gordon Welty, Ph.D.

Gordon Welty, Ph.D. is a consultant and Professor Emeritus at Wright State University, Dayton, OH. Dr. Welty has been involved in designing, developing, facilitating, evaluating, and managing technical and regulatory training programs in the healthcare and pharmaceutical industries for more than 20 years. Dr. Welty also received the 2008 “Article of the Year” award. Congratulations, Gordon!

Kenneth G. Chapman 2009 Achievement Award
Winner: Grace E. McNally

Grace McNally is a senior policy advisor in the US Food and Drug Administration’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance, Division of Manufacturing and Product Quality, Guidance and Policy Team. She participates on several working groups that develop guidance in the areas of process validation, GMPs, and combination products as well as a working group that is revising the CGMPs for finished pharmaceuticals. Ms. McNally chairs the Process Validation Working Group responsible for finalizing the Draft Guidance for Industry Process Validation: General Principles and Practices, published in November 2008. She has served as a compliance officer reviewing domestic GMP cases submitted by FDA district offices. Previously she was an FDA field investigator, and Recall and Compliant Coordinator in the Denver District. The Chapman Award is given to a person who has significantly influenced and contributed to the practice of validation and compliance. Congratulations, Grace!

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