Introduction to 21 CFR Part 11: Electronic Records; Electronic Signatures
This course is delivered on-demand, at your convenience, in 1 module. The module will deliver information to you, let you self-assess your knowledge with review questions interspersed throughout the module, and will culminate with a quiz at the end of the module.
Target Audience: Quality Assurance professionals, IT, business system owners, and management who use GxP-validated systems and would benefit from an introduction to the principles of 21 CFR Part 11
Description: This is an introductory course that explains the contents of 21 CFR Part 11 (Electronic Records; Electronic Signatures), including the scope, Parts, and definitions of the key terms used in Part 11, and provides real-life examples of how to apply Part 11 principles. This course will test your knowledge of Part 11, and successful participants will receive a certificate of completion.
The module objectives are defined at the beginning of the module. By the end of the module you'll be able to accomplish the following objectives:
RQAP re-registration credit:
- Outline the contents of 21 CFR Part 11
- Define key terms in Part 11
- Describe how to apply Part 11 principles
1.16 GLP or non-GCP units for completion of entire module
No refunds will be provided for this course under normal circumstances; under extenuating circumstances, the SQA Board of Directors may consider individual requests for refunds made in writing to firstname.lastname@example.org
. You have one year from date of purchase to complete the course.
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