CEU Credits: 0.1
Course Code: ELM-163
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
1 min 01 secs
Learning Objectives
1 min 31 secs
Who Should Take This Course?
1 min 21 secs
Course Modules
1 min 10 secs
Where is Software Used?
1 min 05 sec
Validation is More than Testing
1 min 10 secs
Scope of this Course
1 min 10 secs
Why Validate – Part 1
1 min 10 secs
Why Validate – Part 2
1 min 07 secs
Hope Through Validation
1 min 24 secs
Regulations, Standards and Guidance
1 min 30 secs
Solid Foundation
1 min 12 secs
Roles, Responsibility and Authority
1 mins 29 secs
Description of the Facility
1 min 02 secs
Implementing the Risk Based Approach
1 min 25 secs
Patient and GxP Impact
1 mins 11 secs
Risk Matrix
1 min 38 secs
Computer System Types
1 min 30 secs
Why is Categorization Important?
1 min 11 secs
Infrastructure
1 min 14 secs
Non-Configured
1 min 01 secs
Configured – IQ
1 min 22 secs
Configured – OQ
1 min 40 secs
Custom
1 min 09 secs
Governance
1 min 18 secs
Configuration Management
1 min 18 secs
Starting and Stopping
1 min 05 secs
Plan for the Unexpected - Test Failure
1 min 39 secs
Plan for the Unexpected – Protocol Issues
1 min 19 secs
Plan for the Unexpected – Expected Results
1 min 30 secs
Approaches
1 min 09 secs
Prospective Validation
1 min 12 secs
Retrospective Validation
1 min 15 secs
Inventory and Classification
1 min 22 secs
Maintaining the Validated State
1 min 31 secs
Conclusion
Final Assessment
Certification
