CEU Credits: 0.1
Course Code: ELM-247
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 09/02/2023
Curriculum for this course
Course Introduction
1 min 25 secs
What You'll Learn
34 secs
Definitions
50 secs
Background on GMP's and Change Control
30 secs
Regulatory Definitions of Change Control
20 secs
What Part do you Play?
21 secs
Types of Change Control
30 secs
Changes in Pharma Industry
44 secs
Levels of Change
8 secs
ICH Q10 Principles
45 secs
Change Management and Continual Improvement
34 secs
US FDA GMP's
10 secs
Global Regulations
7 secs
FDA Warning Letters
37 secs
Warning Letter Citations
1 min
Points to Consider for Building a Change Control Program
7 secs
7 Steps of a Change Control Process
16 secs
Identification
15 secs
Justification
16 secs
Review/Approval
1 min 5 secs
Communication and Training
20 secs
Implementation
24 secs
Closure and Tracking 18 secs
Situation
56 secs
Action
1 min 25 secs
Outcome
1 min 3 secs
Conclusion
1 min 30 secs
What We Covered
15 secs
Test Your Knowledge
Results
Revision History
