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 40+ years involved in all aspects of dissolution testing and 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-Merck Pharmaceuticals Company Analytical Research and Development Section as the Head of the Dissolution Group. In that position, she gained experience in developing discriminating dissolution methods, writing SOP’s and a variety of documents, adhering to strict cGMP practices, filing CMC aspects of dissolution methods and specifications with regulatory agencies and managing a mid-sized laboratory with 10-15 dissolution analysts.

Vivian has been an invited speaker for conferences on 70 occasions (28 of these were International invitations), lecturing especially in the areas of dissolution method development and validation, FDA requirements in dissolution testing, troubleshooting dissolution method problems, and new dissolution technology and dosage forms. She prepares laboratory staff for audits and inspections, and training for method development, validation, recognizing sources of error and importance of observations during the test. She is a proactive participant in the field as demonstrated by 54 publications, including 6 book chapters, contributing to the writing and revising of USP Chapters, initiating change in USP methods, organizing workshops, served on the USP Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, on the PhRMA Dissolution Committee from 1997 to 2001.Vivian has held several offices in the APQ Section of the AAPS, including Chair in 2008. Vivian received the American Society of Hospital Pharmacists Research and Education Foundation 1982 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 task force on Gelatin Crosslinking. Vivian has co- authored a book on dissolution testing called “Handbook of Dissolution Testing”, Third Edition, published in 2004.

In 2002, she formed her own consulting business in dissolution testing and related areas. The company name is V. A. Gray, Consulting, Inc, www.vagrayconsulting.net . In June of 2003, she became Managing Director of Dissolution Technologies, a peer-reviewed journal dealing specifically with dissolution testing issues, www.dissolutiontech.com




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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