In-Depth Pharma Training in Bethesda

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

  • Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
  • Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
  • Global Training to Fit Your Needs:  With classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

GAMP 5, Annex 11/Part 11 Basic Principles

05 - 07 Dec

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.

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Instructor

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.