CEU Credits: 0.1
						
					
							Course Code: ELM-133
						
					
							Duration: 60 mins
						
					
							Skill Level: Intermediate
						
					
							Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)
						
					
							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