Gary Ritchie

Principal Consultant

CAI

Biography

Gary’s career highlights include:

-Former Director of Operations and Regulatory Affairs Analyst for Dynalabs, LLC located in St. Louis, MO.

-Internationally recognized expert in multivariate spectroscopic analysis, pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near-infrared, Raman and multivariate analysis.

-Nineteen years of industry experience with increasing responsibility

-Five years of policy experience and ongoing consulting experience in the pharmaceutical and biopharmaceutical industry

-Scientific Fellow for Process Analytical Technology (PAT) with the United States Pharmacopeia (USP) and Liaison to the General Chapters, Pharmaceutical Waters and Statistics Expert Committees from 2003 through 2008.

-As a USP in-house expert on the FDA Process Analytical Technology and Quality by Design Initiative, he was responsible for over thirty Pharmacopeial chapter revisions that incorporated and reflected the revisions by the FDA on the 21st Century cGMP Initiatives. He also led collaborations on several FDA, USP and industry projects that resulted in several Pharmacopeial standards.

-Twenty-nine peer reviewed papers and book chapter contributions; four issued patents, numerous industry journal articles and has been invited to give many conference and symposia presentations worldwide.

-Former President of The Council for Near-Infrared Spectroscopy (2012-2014).

-Master of Science and Bachelor of Arts degrees in Biology from the University of Bridgeport.”

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