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
- Author: LilburnSteven