Good Manufacturing Practices (cGMP) - Intermediate

Deviation – Investigator

This course provides a comprehensive overview of the deviation investigation process in quality assurance. In this course, you will learn the process of effectively conducting deviation investigations, identifying root causes, and implementing corrective actions to prevent future deviations. We will cover essential topics such as team formation, data collection, root cause analysis, and report writing.

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CEU Credits: 0.1
Course Code: ELM-197
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 09/03/2024

Curriculum for this course

Almost the Weekend
The Importance of a Thorough Investigation
Investigation Goals and Objectives
Investigation Steps
Step 1: Assemble the Investigation Team
Step 2: Brainstorm Potential Causes
Root Cause Tools
Check-in 1
Step 3: Developing Your Investigation Plan
Step 4: Gathering Your Data
Step 5: Compiling Data; Determining Root Cause
Check-in 2
Step 6: Writing the Report
Historical Review
Background
Investigation Summary
Final Impact Assessment
Your Audience
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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