Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This three-day course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. This course includes the revised EU GMP Annex 11 and an update on 21 CFR Part 11.
James W. (Jim) John, PMP, is a Senior Project Manager with ProPharma Group and 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. Prior to ProPharma John worked for Rockwell Automation and several compliance consulting companies dealing in the FDA Regulated industries.