An introduction to FDA 21 CFR PART 11

5/5
46
An introduction to FDA 21 CFR PART 11

Duration :

12

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Description:

The main goals of this e-learning course are to give learners a grounding in the principles of and latest requirements for Electronic Records regarding FDA 21 CFFR PART 11. The training provides an overview of the FDA requirements with practical examples covering the implementation of those requirements. The course covers the application of these requirements to both hardware and software systems used in Manufacturing, QA, Regulatory, validation and the Control of Processes.

 

In this course, we provide a synthesis on the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction
Overview
Learning objectives
Who should take this course
Program introduction

 

Module 1: The Predicate Rules
21 CFR Part 11 explained
Electronic records
What are the predicate rules?
Relationship to the predicate rules
Predicate rules and batch records
Electronic signatures
Handwritten signatures

 

Module 2: What is Part 11
What is 21 CFR Part 11?
Guideline
Narrow scope and application of Part 11
The benefits

 

Module 3: E-Signatures and E-Records Explained
E-Signatures not impacted

 

Conclusion

 

Final Exam

 

Certification

Author:

An introduction to FDA 21 CFR PART 11
Dorothy R. Lang
Manager - Quality Compliance at Glatt Pharma

Reviews:

5/5
46

$47.50 $95

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Certificate of completion

$47.50
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