A UL EduNeering course
The principal purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with FDA’s mission of public health and safety.
This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11.
- Part 11
- Basic and security requirements for electronic records
- Basic requirements for electronic signatures
- Controls for electronic signatures
- FDA enforcement of Part 11
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields