James W. (Jim) John is a Project Lead with Altus Automation, a ProPharma Group Company. He has worked with clients in the areas of pharmaceutical project management, validation and Part 11 remediation in the manufacturing and laboratory environments for the past 15 years. Jim worked for Rockwell Automation and several compliance consulting companies dealing in the FDA Regulated industries. Jim began his career working in plant operations and engineering in the chemical industry with BASF followed by several years working in the Manufacturing IT Group at Nabisco. He has served on guideline development committees for ISPE (including GAMP®) and PDA, and has had papers published by ISA, Pharmaceutical Online, and ISPE's Pharmaceutical Engineering magazine. In addition, Jim has served as a featured speaker on validation issues at conferences in the U.S., Canada, Europe, and Japan. His professional affiliations include: chairman of the JETT Consortium, a special interest group of ISPE's GAMP Americas Forum, member of the GAMP Americas Steering Committee, Industry Advisory Board Member for PDA's Audit Repository and training developer and presenter for FDA in-house training for CSV.