Description
Title 21 of the
U.S. Code of Federal Regulations Part 11 (21 CFR Part 11) outlines the Food and
Drug Administration’s (FDA’s) requirements for electronic records and
electronic signatures. It is
designed to prevent fraud while permitting the widest possible use of
electronic technology.
FDA’s Final Guidance was published in August 2003.
This course will help you understand the background, when it applies, and
the key requirements.
This course will cover:
·
Background
of 21 CFR Part 11
·
Discussion
·
Key Requirements
·
Scope of
Part 11
·
Specific
Part 11 Requirements
·
Quiz
