Consulting services in dissolution testing and related areas for the pharmaceutical industry, dietary supplements arena, regulatory agencies, and equipment vendors.


Expertise:
Often the Dissolution Test draws questions from regulatory agencies. Vivian can assist you in assessing your current methods and in developing new methods that are discriminating and can withstand regulatory scrutiny. This would also include method development and validation of special or novel dosage forms, and assistance in utilizing the Biopharmaceutics Classification System.

Vivian can also provide expert advice for litigation and can provide laboratory testing of products and/or method development and validation. She can train your analysts to understand the utility of observations and learn the many sources of error in testing. Vivian can prepare your staff for audits and inspections. She can show ways to increase your productivity and efficiency.

Her expertise includes selection and justification of specifications as well as preparation and review of regulatory documents.



Career Summary:
Vivian has spent the last 31 years involved in all aspects of dissolution testing including evaluating new dissolution technology. At the United States Pharmacopeia, she enjoyed a long career serving first as a bench chemist, supervisor, and, lastly, as a liaison to various expert USP committees, including the Biopharmaceutics and Dissolution Expert Committee. In 1997, Vivian joined the DuPont Pharmaceuticals Company Analytical Research and Development Section as the Head of the Dissolution Group. In that position, she was responsible for developing discriminating dissolution methods, writing SOPs and a variety of technical documents, adhering to strict cGMP practices, and filing CMC aspects of dissolution methods and specifications with regulatory agencies. In 2002, she formed her own consulting business in dissolution testing and related areas. The company name is V. A. Gray Consulting, Inc. In June of 2003, she became Managing Director of Dissolution Technologies, a peer-reviewed journal dealing specifically with dissolution testing issues.

She has been an invited speaker for conferences on 29 occasions, lecturing in the areas of calibration, dissolution equipment, sources of error in dissolution testing, method development and validation, new technology, and regulatory topics. She is a proactive participant in the field as demonstrated by 39 publications, writing and revising USP Chapters, initiating change in USP methods, organizing workshops, and serving on the USP Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, and the Editorial Board for Dissolution Technologies. She served on the PhRMA Dissolution Committee from 1997 to 2001.




Awards:
Vivian received the American Society of Hospital Pharmacists Research and Education Foundation Research Award for co-authoring an article on packaging using USP calibrator model tablets and received the FDA Commissioner's Special Citation for involvement in the FDA Working Group on Gelatin Capsules.

 

 

 

 

 
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