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
  
  • Example Part 11 Compliance SOP
  • Part 11 assessment spreadsheet
  • Part 11 inventory spreadsheet

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