Friday, May 09, 2008
FDA COMPLIANCE SOLUTIONS RESOURCES
FDA Compliance Solutions, Inc., through our employees, associates and partners offers the extensive and comprehensive resources need for your compliance solution.
Our highly successful experiences with more than 500 completed projects, (none ever cited by the FDA) and with having trained more than 2000 professionals we are truly unique.
Our resources include the rules, tools, staff, experience and expertise to provide the highest quality, cost effective solutions to the FDA regulated Industries.
OUR FOUNDER
Philip E. Sax is Principal and President of FDA Compliance Solutions, Inc. Since 1987 Phil has been providing computer validation and compliance services to FDA regulated organizations throughout the world. His expertise and experience in system validation, compliance, submissions, medical devices, GMPs, GLP, GCP, PDMA, EU, OECD, ISO and Quality Systems, Risk Assessment, and training have earned him a well-deserved international reputation for excellence and integrity.
Phil holds a Masters of Government Administration from the Wharton School, University of Pennsylvania, a Bachelors Degree from Rutgers University and he is a PhD. candidate at the California Coast University. Mr. Sax served on the business and political science faculties at Rutgers University and he has been a lecturer of Production Management at La Salle University. He has also guest lectured at Temple, Drexel and Penn State Universities
Since 1987, Phil has served as the Director of Computer Validation Seminars at The Center for Professional Advancement, where he has trained more than 2500 professionals. He also conducts workshops for Barnett International, The Institute of Validation Technology and Morris County College.
As a Co- Founder and CEO of Weinberg, Spelton and Sax Inc, Mr. Sax was an early pioneer in professionalizing and defining computer system validation and related compliance services and training. Phil also founded WSS Compliance Services, Inc., the predecessor to FDA Compliance Solutions Inc.
Phil has provided consulting and training to many of the industry’s leading organizations. His unique experiences include serving as the managing partner for the American Red Cross System Certification Program, Consulting to the Canadian Blood Services, and he testified to the US Congress on Blood System Validation Issues.
He has also consulted to: Johnson and Johnson, Hoffman La Roche, Rorer, Plasma Alliance, McNeil, Hewlitt Packard, Digital Systems, IBM, Syntex, Genentech, Gensia, Neutrogenia, E.I Dupont, Amgen, Baxter, Immuno US, Hyseq, Perkin Elmer-Nelson, Astra, Pharmacia, Organon, Solvay DuPharm, Pliva, Consolidate laboratories, Cell Therapeutics, Genzeme, Hoersct, Ciba Giegy, Interpharm, DAD, Shaklee Corporation, Ortho, Fuji, Schiapparelli Bio Systems, Life Sourse, Hemacare/Mediware, ETCOM, Rhode Island Blood Center, Smith Kline, Mt Sinai Hospital, Sligos, UCLA Harbour Blood Center, ISIS, Purdue Frederick, The Wister Institute, Beth Israel Hospital, Soft Computer Consultants, Meditech, Mosum Ltd., IDM, Nextran, Mission Pharma, BioMira, Thomas Jefferson University, CYGNEX, Harvard Medical School, ESI Phoenix Marketing, Martech, Medcomp, MDI, NIH, ACCESS World Wide, Ross Systems, Lavipharm, Medtox, Mack Molding, Bosniajek, Sandoz, STERIS, Schering Plough, Dial Soap, The USFDA, EPA and many other leading firms and organizations.
Phil has worked with FDA regulated companies throughout the world to train their staffs, validate systems and develop regulatory strategies and processes. He has contributed chapters to several books and has published articles on economic issues, system validation, project management and other topics. He has also served as a Principal of a Big Eight consulting organization and was the Vice Chairmen of the Board of the Cherry Hill Economic Development Corporation.
He is a well know speaker, consultant and educator.