Fundamentals Series

The Fundamentals of Change Control

This course will give you a high-level understanding of Change Control practices in the pharmaceutical industry.  It is important to evaluate all changes that could affect the production and control of the drug product, intermediate or active pharmaceutical ingredients (API) in a pharmaceutical manufacturing company.

For this reason, a change control system is a vital part of the overall quality management system for drug product manufacturing — often referred to as the pharmaceutical quality system.

Book a Demo
CEU Credits: 0.1
Course Code: ELM-247
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 02/09/2023

Curriculum for this course

Course Introduction
What You'll Learn
Definitions
Background on GMP's and Change Control
Regulatory Definitions of Change Control
What Part do you Play?
Types of Change Control
Changes in Pharma Industry
Levels of Change
ICH Q10 Principles
Change Management and Continual Improvement
US FDA GMP's
Global Regulations
FDA Warning Letters
Warning Letter Citations
Points to Consider for Building a Change Control Program
7 Steps of a Change Control Process
Identification
Justification
Review/Approval
Communication and Training
Implementation
Closure and Tracking
Situation
Action
Outcome
Conclusion
What We Covered

Test Your Knowledge

Results

Minor update to new navigation standards
V1.1

Author

Mike LaBruto

Executive Director, QA

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learn More

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Learn More

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.

Learn More