Sid Rubinstein is a
Principal in the consulting firm Regulatory Compliance Initiatives,Inc.(RCI),and has more than 25 years experience in the pharmaceutical
industry, including over 17 years as a consultant. He specializes
in current Good Manufacturing Practice (cGMP) regulations, Quality
System requirements, and developing and directing regulatory corrective
action initiatives.
As a consultant, Sid
founded MediPharm International Consultants, Ltd., a
firm specializing in performing audits of US and foreign pharmaceutical
manufacturers of active pharmaceutical ingredients, all finished
dosage forms, dietary supplements and nutraceuticals, and biotechnology
products.
He has successfully prepared clients for FDA
Pre-Approval Inspections (PAI), and has directed clients in the
preparation of Standard Operating Procedure (SOP) and Quality System
Manuals, as well as Corrective and Preventative Action (CAPA) Programs.
Sid is also a founder
and a Principal in HP BioPharm Technologies, Ltd. and Cox&Fay, Inc., companies dedicated to working with US and foreign firms requiring
assistance with drug development and clinical research project
management, and with plans for designing new turnkey manufacturing
facilities, respectively.
Prior to his consulting career, Sid was Vice President-Operations
and Compliance for Dell Laboratories, Inc., Edward Mendell Company,
Inc., and The Vitarine
Company, Inc.
Sid has a BS degree in Pharmacy from Columbia
University College of Pharmaceutical Sciences, and has practiced
community pharmacy.
