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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:

  • 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:   1.16 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 You have one year from date of purchase to complete the course.

Bulk Pricing: If you are interested in buying five or more online learning programs (five instances of one course for your staff, five separate courses for yourself, or any combination thereof), please download our Online Learning Bulk Order Form.

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