Good Manufacturing Practices (cGMP) - Intermediate

Deviation – Initiator

In this course, you will learn more about initiating deviations and deviation records, including best practices and mistakes to avoid. You’ll also learn about the short description, full description, and immediate actions or corrections and their use in deviations. 

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CEU Credits: 0.1
Course Code: ELM-196
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 08/14/2024

Curriculum for this course

Course Introduction
Consequences of Poor Documentation
Deviation Record Audience
Deviation Record Best Practices
Avoid Common Deviation Record Mistakes
Deviation Record Practice
Deviation Record Improved
Deviation Record Practice Continued
Deviation Initiation Elements
Short Description
Description
Description Guiding Questions
Description Example
Improved Description Example
Product X Incident Description
Immediate Actions or Corrections
Initiation Pitfalls
Historical Reviews: Looking for Trends
Next Step: Initial or Draft Impact Assessment
Summary
Test Your Knowledge
v1.0 - Course Released on 10/29/2024

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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