Timothy Howard is a Vice President at Commissioning Agents, Inc. and leads the regulated Commissioning and Validation services business area. He also provides Commissioning and Validation program consulting and project planning services. Howard has 16 years of pharmaceutical / biotechnology industry experience. Howard is the co-chair of the ISPE C&Q COP, and past chair of ISPE’s North American Education Committee. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 on science and risk base qualification and a contributing author to draft ISPE Guidance Documents on ASTM E2500 Implementation. Howard is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars, and is published in Pharmaceutical Engineering. Howard is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional (CPIP), and a registered professional engineer in North Carolina.