Process Validation

Process Validation: Core Concepts

Process validation helps us establish that a process is capable of consistently delivering a quality product. The goal of this course is to give you the “big picture” of process validation so that you can see yourself and your role in the process. This course will equip you with a standardized, deep understanding of the core concepts and principles of process validation.

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CEU Credits: 0.1
Course Code: ELM-401
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 10/16/2023

Curriculum for this course

Course Introduction
What You'll Learn
Verification and Qualification
Process Validation
Why Validate Processes?
Types of Validation
Situations
Product Life Cycle
What Processes to Validate
General Considerations for Process Validation
Stage 1: Process Design
Stage 2: Process Qualification
Stage 3: Continued Process Verification
Course Conclusion

Final Exam

Certification

Improved course functionality
V1.1
Fixed issue. The on-screen text slide titled Fundamental Terms failed to display correctly.
V1.2
Major Update: This course has been redesigned. The course content, objectives, and visual design have been streamlined and updated to comply with the latest learning theory advances and process verification methods
V2.0

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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