Online Learning Center

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.

Objectives:
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:

  • Outline the contents of 21 CFR Part 11
  • Define key terms in Part 11
  • Describe how to apply Part 11 principles

RQAP re-registration credit:   0.29 GLP or non-GCP units for completion of entire module

Member Price:  $75.00
Nonmember Price:  $125.00

Policies: 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 sqa@sqa.org. You have one year from date of purchase to complete the course.

Bulk Pricing: If you are interested in buying one or more online learning programs for 5+ individuals and would like to inquire about bulk pricing, please contact sqa@sqa.org.

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