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- Introduction to 21 CFR Part 11
Introduction to 21 CFR 11
$299 USD
Add to Cart will direct you to
Registrar's MyFDA portal to complete your transaction
Learn about Part 11 of Title 21 of the Code of Federal Regulations, which establishes the United States Food and Drug Administration (FDA) regulations for electronic records and electronic signatures.
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Benefits
Overview
Throughout the early 1990’s, computerized systems were being widely used by FDA-regulated industries, such as pharmaceuticals, cosmetics, and various manufacturing facilities.
As of August 20, 1997, the FDA allowed electronic records and electronic signatures to be used in place of paper records and pen and ink signatures, so that business can be conducted digitally. Organizations who move to electronic systems see improvements in standardization, productivity, and efficiency.
The goal of Part 11 (as it is commonly called) is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures.
Detailed in this course are the various components of Part 11 and how to properly integrate electronic records and signatures into your organization.
What's Included
Self-paced, practical online training
Downloadable student notes
Contents
1. Electronic Record and Electronic Signatures
2. Subpart A – General Provisions
3. Electronic Records
4. Electronic Signatures
5. Specific Part 11 Requirements
$299 USD
Add to Cart will direct you to
Registrar's MyFDA portal to complete your transaction
100% Online
No prerequisites required
Complete on your own time
What's Included
- Self-paced, practical online training
- Downloadable student notes
