CEU Credits: 0.1
Course Code: ELM-133
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/29/2022
Curriculum for this course
Overview
Learning objectives
Who should I take this course?
Course modules
Where is software used?
Validation is more than testing
Scope of this course
Why validate – Part 1
Why validate – Part 2
Hope through validation
Regulations, standards and guidance
Waterfall model
Iterative / Agile approach
Core processes
Requirements
Specification and design
Design is hierarchical
Design & validation
Verification
Commercial software - Part 1
In-house software
Acceptance & release
Modifications since the last release
Known issues
Configuration information
Support processes
Risk management
Design review
Change management – Part 1
Change management – Part 2
Configuration management
Retirement
Commercial software - Part 2
Define your process
Validation and the quality management system (QMS) – Part 1
Validation and the quality management system (QMS) – Part 2
Conclusion
Final Assessment
Certification
Minor assessments and objectives rewritten
V1.1