21 CFR Part 11

In August 1997, the FDA gave the industry a set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of the Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, explains the role that Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.
 
After completing this course, participants should be able to:

  • Describe how the need for regulations on electronic records led to the creation of Part 11
  • Identify the Part 11 regulations and their scope
  • Explain how Part 11 relates to other sections of 21 CFR
  • Describe why Part 11 compliance makes both legal and business sense
  • Explain the FDA trickle-down theory of regulation
  • Identify the main areas of security concern and the implications of threats in these areas
  • Explain how passwords are used to protect data and the importance of NOT sharing passwords

Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.