FDA 21 CFR Part 11 Electronic Signatures-Requirements
This ON DEMAND 1-hour e-course teaches a brief overview of the key concepts and major requirements of the FDA Part 11 Electronic Records and Signatures and includes certified training Certificate of Competence. 0.1 CEUs.
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Course curriculum
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1
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1 - How to use this course
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2
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Electronic Signatures_Lesson-02
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Electronic Signatures_Lesson-02_QUIZ
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3
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Electronic Signatures_Lesson-03
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Electronic Signatures_Lesson-03_QUIZ
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4
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Electronic Signatures_Lesson-04
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Electronic Signatures_Lesson-04
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5
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Congratulations
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Learning Objectives
Upon completion of this training, students will be able to:
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Interpret the clauses and recognize the application of Part 11
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Understand the roles and responsibilities to support compliance to the standard
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Understand requirements to inform FDA of intent to use electronic signatures
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Be prepared for Part 11 inspections
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Course Categories
Lead Auditor | Internal Auditor | Requirements | Overview
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