Jeffrey Gassman, Bsche, Msche Email & Phone Number

I have been helping people at pharmaceutical, biotechnology, and medical device firms with validation and quality over 35 years. My technical education includes a Bachelor's Degree in Chemical Engineering from Clarkson University and a Master's Degree in Chemical Engineering from Columbia University. I have supplemented them with non-technical courses including Dale Carnegie and the American Management Association's Course in Project Management. Thanks to my mentors, I've read and re-read dozens of books regarding people skills (I have a library of them). I listen to people, ask them about the issues they are facing, and perform validation/implement quality solutions that exceed their expectations. I have received dozens of letters of recommendation, have been inducted into Who's Who in Science and Engineering in America, and have received multiple awards from the Small Business Commerce Association.I've been fortunate enough to be able to validate equipment, facilities, and software in the US, Canada, Europe, and Asia, from the HIV and Hep C diagnostic tests in the late 1980s, to facilities used to manufacture COVID vaccines. I've helped multiple start-up firms with quality and validation (which have subsequently become multi-billion dollar corporations). I've helped multiple companies commission and validate new facilities and expand existing facilities.These activities have allowed me to meet and work with some of the top validation, quality, and regulatory consultants in the world. Sometimes they assemble a team and ask me to join them. Sometimes, I'm fortunate enough to assemble a team and ask them to work with me.These opportunities have allowed me to travel to many exciting places including, but not limited to: Hainan Island (China), Taj Mahal (India), Seoul (South Korea), Jerusalem's Old City (Israel), and Windsor Castle (England).I enjoy travel, hiking, exploring new places, movies, dining out, and playing poker with the guys (very small stakes). Last year, my wife and I travelled to Moab, UT and visited two national parks. Later this year, we will be driving up to Steamboat Springs, CO with friends. Next year, we will be cruising to Alaska.

Listed skills include Validation, Fda, Computer System Validation, Quality Assurance, and 45 others.

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  President

  Validation Plus, Inc

  Dec 1995 - Present - 6909 Egyptian Drive, Colorado, Us

  Validation Plus Inc (VPI) is the name of my company. I've been helping pharma, biotech, and medical device clients through VPI since 1995, and have received dozens of recommendations for exceeding their expectations. I got my start in 1986 at Pharmafair manufacturing aseptic products and performing validation. In 1988, Chiron "made me an offer I couldn't refuse". They were a start-up biotech firm. My colleague and I were their validation team. We validated their HIV, Hepatitis C, and Hepatitis B Core diagnostic products and got them expedited FDA approval which made them hundreds of millions of dollars. Since 1995, I've assisted dozens of clients with validation and quality, from start-ups to the 5 largest pharma companies. This includes equipment, utility, facility, analytical, process, cleaning and hardwire and software validation. I've managed multi-national projects and up to 15 projects simultaneously. I've performed over 300 audits world-wide. I've set up Quality Systems for 3 start-up firms. I've validated dozens of software applications and 40+ processes. I've assisted with 8 facility startups and expansions. I've worked in the US, Canada, India, China, South Korea, Israel, France, Germany, England, and Switzerland. I validated the filling lines at multiple companies used for the COVID vaccine. I've mentored and taught validation internationally through the Institute of Validation Technology and the ISPE. There are a lot of "I's" above; sometimes clients hire me, sometimes clients ask me to assemble a team, and sometimes clients ask me to work with their people. If you have a project and it needs to be done right the first time, perhaps it's time for me to help? Or if you have a project that is now over-budget/over-time, perhaps I can help. (You can think of me as the "Validation A Team". I can come in by myself, or assemble a team of the top validation, quality, and regulatory people [people I've worked with closely] to help you.) I'm ready to help you