What Will You Learn?


  • What 21 CFR Part 11 regulation is
  • What Electronic Records and Electronic Signatures are and which ones are subject to the requirements of Part 11
  • What Part 11 requires for compliance
  • How to interpret some arcane Part 11 regulation terms in today's rapidly advancing mobile computing world
  • How to manage computerized systems in your company with respect to Part 11
  • How to evaluate a system for Part 11 compliance (Gap Analysis)
  • Some practices for achieving compliance to Part 11 with your own eRecords and eSignatures


What Will You Get?


  • Unlimited access to this course for as long as the course remains in the active curriculum
    • take as long as you need to complete the course
    • revisit as often as you like
    • refresh the acquired knowledge whenever you need

  • Intelligent, thought provoking and entertaining quizzes and exams
    • challenging questions designed by experts
    • randomly pulled questions from a larger library of questions
    • passing the quizzes and exams is mandatory for successfully completing the course
    • provides an effectiveness measure for the training

  • Course Materials


Certifications


  • Certificate of Completion
    • upon review of critical amount of course content
    • upon successfully passing the quizzes and final exam

  • Subject Matter Expert (SME) Badge
    • This course is part of the "eSecurity and ePrivacy" and "Software Validation" SME Certifications. It takes you one step closer to earning those SME Badges.


SuperSmart Points


  • You earn 10 SuperSmart points for taking this course.
  • You need to redeem 60 SuperSmart points to take this course for free.


And More...


  • Ongoing interactions and networking with other course participants
  • Interactions and follow-up questions with the course author
  • Provide rating and review comments on the course