Change Control

Change Control: Core Concepts

In this course, we look at core concepts of change control. We start with the definition and regulations before moving on to some historical case studies to learn why change control is so important. We finish with a high-level look at the roles involved in change control and the general process that is followed.

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CEU Credits: 0.1
Course Code: ELM-250
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 02/07/2024

Curriculum for this course

Breaking News
Course Introduction
What is Change Control?
Change Control Regulations
L-Tryptophan Outbreak
Change Control Roles and Responsibilities
The Change Owner
SME's
Regulatory Affairs
Area Managers
Reviewers
Change Control Board
QA
Identification of Need
Scope
Assessment
Plan
Review
Implementation
Verification and Close
Summary
What We Covered

Test Your Knowledge

Minor Update: Updated to fix typo
V1.1

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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