CEU Credits: 0.1
Course Code: ELM-157
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Course Overview
Learning Objectives
Who Should Take This Course?
Product Life Cycle Validation – Part 1
Product Life Cycle Validation – Part 2
The Four Validation Flavors
Risk Considerations
Software Considerations
Product Validations – Non-Comprehensive List
Product Validations - Closer Look at Efficacy and Usability
Product Validation Plan
Product Validation Plan – The Outline
Activities
Responsibilities
Strategies, Tools and Methods
Test Entry / Exit Criteria
How Issues are Reported and Dispositioned
Resources Required
Reporting
Protocol Construction – Regulatory
Protocol Construction – Expectations Part 1
Protocol Construction – Expectations Part 2
Results
Test Failures and Issues
Test Failures and Issues – Example 1
Test Failures and Issues – Example 2
Reporting – Part 1
Reporting – Part 2
Individuals Performing Validation Work
Dates Validation Performed
Identification of Inputs (Materials) Used
Identification of Equipment Used
Objective Evidence of Meeting Expected Results
Disposition of all Test Failures and Safety Assessment
Conclusions (Safe, Effective, Compliant)
Setting the Scene
Enzyme Analysis Systems Validations – Safety and Efficacy Part 1
Enzyme Analysis Systems Validations – Safety and Efficacy Part 2
Enzyme Analysis Systems Validations – Packaging and Transportation
Enzyme Analysis Systems Validations – Packaging and Transportation
Programming Software
Device Software
Reporting Software
Conclusion
Final Assessment
Certification
