James W. (Jim) John is a Project Management Quality Consultant with 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 fifteen years. John worked for Rockwell Automation and several compliance consulting companies dealing in the FDA Regulated industries. John 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, John 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 COP), member of the GAMP Americas Steering Committee, member of ISPE's North American Education Committee and training developer and presenter for FDA in-house training for CSV.