Russell E. Madsen
Russell E. Madsen is a Pharmtech editorial advisory board (EAB) member.
Russell E. Madsen
President, The Williamsburg
Group, LLC
Russell E. Madsen is president of The Williamsburg Group, LLC, in Gaithersburg, Maryland, which is engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, regulatory liaison and general technical services. Most recently, he had served PDA as acting president and was senior vice-president of science and technology, responsible for the overall scientific, technical and regulatory affairs activities of the association.
Before joining PDA, he was employed by Bristol-Myers Squibb as director of technical services, providing technical and general consulting services to Bristol-Myers Squibb pharmaceutical, medical device, nutritional, and cosmetic operations worldwide. He currently is vice-chairman of ASTM E55.03 General Pharmaceutical Standards, serves as a member of the USP Parenteral Products-Industrial Expert Committee, is a member of Pharmaceutical Technology’s editorial advisory board, and is senior technical documents advisor to ISPE. Madsen holds a BS from St. Lawrence University and a MS in Chemistry from Rensselaer Polytechnic Institute.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
