21 CFR Part 11 - Electronic Records; Electronic Signatures

This 21 CFR Part 11 - Electronic Records; Electronic Signatures online training course explores the compliance requirements for companies regulated by the U.S. Food and Drug Administration (FDA) that use electronic records and electronic signatures. Employees of these life science companies will learn what types of electronic records are subject to Part 11, the system and administrative controls your company needs to implement and document, and how electronic signatures must be managed.

Course Learning Objectives

By taking this online 21 CFR Part 11 - Electronic Records; Electronic Signatures course, the user will learn:

• What electronic records must be compliant with 21 CFR Part 11
• The system and administrative controls and documentation required for Part 11 compliance
• The requirements for ensuring that electronic signatures are Part 11 compliant

Course Outline

This online 21 CFR Part 11 - Electronic Records; Electronic Signatures course is made up of the following sections:

1. Subpart A - General Provisions
2. Subpart B - Electronic Records
3. Subpart C - Electronic Signatures
4. Further Thoughts on Part 11

Course Audience

This 21 CFR Part 11 - Electronic Records; Electronic Signatures online training course was designed for employees of life science companies regulated by the U.S. FDA.

If you have any concerns as to whether this course is appropriate for you or your industry, please browse our full selection of online courses.