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: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/02/2024

Curriculum for this course

Breaking News
53 secs
Course Introduction
32 secs
What is Change Control?
58 secs
Change Control Regulations
11 secs
L-Tryptophan Outbreak
58 secs
Change Control Roles and Responsibilities
47 secs
The Change Owner
42 secs
SME's
55 secs
Regulatory Affairs
23 secs
Area Managers
52 secs
Reviewers
30 secs
Change Control Board
33 secs
QA
1 min 21 secs
Identification of Need
45 secs
Scope
22 secs
Assessment
1 min
Plan
48 secs
Review
28 secs
Implementation
21 secs
Verification and Close
55 secs
Summary
24 secs
What We Covered
18 secs

Test Your Knowledge

Results

Revision History

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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