Vivian Gray
V. A. Gray Consulting, Inc.
9 Yorkridge Trail
Hockessin, DE, 19707
Phone:
(302) 235-0621
Fax:
(443) 946-1264
E-mail: vagray@rcn.com
Web Page: www.vagrayconsulting.net
Expertise:
Often the Dissolution Test draws questions from regulatory agencies. Vivian can assist you in assessing your current methods and develop 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.
Justification and selection of specifications is an area of expertise and also writing/reviewing regulatory documents.
Work History:
Vivian has spent the last 27 years involved in all aspects of dissolution testing and evaluating new technology. She enjoyed a long career at USP 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 as head of the dissolution group in the Analytical R & D Section. In that position, she directed the development of discriminatory dissolution methods, adhering to cGMP practices, and wrote dissolution sections of CMC filings and chose specifications.
In January 2002, she formed her own consulting company in the area of dissolution testing.
Career Summary:
Vivian has lectured frequently, especially in the areas of calibration, dissolution equipment, gelatin crosslinking, sources of error, method development, and regulatory topics. She is a proactive participant in the field as demonstrated by over 30 publications, writing and revising USP Chapters, initiating change in USP methods, in-depth work with calibration, organizing workshops, serving on the USP Expert Biopharmaceutics Committee, the USP Calibration Project Team, the FIP (International Pharmacy Federation) Dissolution Working Group, and as a Research Editor for the publication, Dissolution Technologies.
She 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.
