Change Control: Regulations and Guidelines
Description:
In this program, we will focus on providing an in-depth understanding of performing change control and change management for organizations functioning within the life sciences industry (and related companies), including pharmaceutical and medical device manufacturers. Change control is a well-known good manufacturing practices (GMP) concept that focuses on managing change to prevent unintended consequences, maintain processes in a suitable state, such as in a “validated state,” and prevent any consequence of the change on the products’ Safety, Integrity, Strength, Purity and Quality (SISPQ). Change control has several different explanations, depending on the area to which the concept is applied.
Curriculum for this course:
Program Introduction
| Overview: Defining Change Control | 1 min 01 secs |
| Learning Objectives | 1 min 31 secs |
| Who Should Take This Program? | 1 min 21 secs |
| Glossary | 1 min 10 secs |
Change Control Basics
| Change Control Industries | 1 min 05 sec |
| Overview of U.S. Regulations | 1 min 10 secs |
| Benefits of Change Control | 1 min 08 secs |
| Industries under US FDA Regulations for Change Control | 1 min 17 secs |
| FDA 21 CFR Part 211 on Change Control | 1 min 48 secs |
| Defining Change Control: EU GMP | 1 min 24 secs |
| EU Annex 15 on Change Control | 1 min 30 secs |
| International Requirements for Change Control | 1 min 08 secs |
| Summary of Change Control | 1 min 30 secs |
Conclusion
Final Assessment
Certification
Revision History
| Updated to v3.0 on 08/13/2021 Question on assessment fixed | Version 3.0 |
| Assessment Updated | Version 2.0 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-159 -
Duration: 30 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: 3.0 -
Effective Date: 13/08/2021
Reviews:
This is an essential course for anyone working in the life sciences. Change control is not only critical for your business bit it’s also a regulatory requirement!
Related courses:
Risk Based Equipment Qualification
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
cGMP – Equipment, Validation, Complaints and Self Inspection
How to Perform Supplier Qualification
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