An Introduction to Medical Device Validation – Part 2
Description:
This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with validation or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from taking this course. No experience of validation is necessary though some knowledge of processes would be beneficial.
Curriculum for this course:
Introduction
Course Overview | 1 min 01 secs |
Learning Objectives | 1 min 31 secs |
Who Should Take This Course? | 1 min 21 secs |
Module 1: The Starting Point
Product Life Cycle Validation – Part 1 | 1 min 15 secs |
Product Life Cycle Validation – Part 2 | 1 min 10 secs |
The Four Validation Flavors | 1 min 08 secs |
Risk Considerations | 1 min 17 secs |
Software Considerations | 1 min 48 secs |
Module 2: Product Validations
Product Validations – Non-Comprehensive List | 1 min 20 secs |
Product Validations – Closer Look at Efficacy and Usability | 1 mins 29 secs |
Product Validation Plan | 1 min 02 secs |
Product Validation Plan – The Outline | 1 min 25 secs |
Activities | 1 min 10 secs |
Responsibilities | 1 min 48 secs |
Strategies, Tools and Methods | 1 mins 23 secs |
Test Entry / Exit Criteria | 1 min 39 secs |
How Issues are Reported and Dispositioned | 1 min 14 secs |
Resources Required | 1 min 01 secs |
Reporting | 1 min 22 secs |
Module 3: Protocol Construction
Protocol Construction – Regulatory | 1 min 01 secs |
Protocol Construction – Expectations Part 1 | 1 min 13 secs |
Protocol Construction – Expectations Part 2 | 1 min 33 secs |
Results | 1 min 06 secs |
Test Failures and Issues | 1 min 19 secs |
Test Failures and Issues – Example 1 | 1 min 27 secs |
Test Failures and Issues – Example 2 | 1 min 55 secs |
Reporting – Part 1 | 1 min 03 secs |
Reporting – Part 2 | 1 min 25 secs |
Individuals Performing Validation Work | 1 min 28 secs |
Dates Validation Performed | 1 min 32 secs |
Identification of Inputs (Materials) Used | 1 min 08 secs |
Identification of Equipment Used | 1 min 01 secs |
Objective Evidence of Meeting Expected Results | 1 min 11 secs |
Disposition of all Test Failures and Safety Assessment | 1 min 14 secs |
Conclusions (Safe, Effective, Compliant) | 1 min 19 secs |
Module 4: Device Product Validation Example
Setting the Scene | 1 min 10 secs |
Enzyme Analysis Systems Validations – Safety and Efficacy Part 1 | 1 min 01 secs |
Enzyme Analysis Systems Validations – Safety and Efficacy Part 2 | 1 min 25 secs |
Enzyme Analysis Systems Validations – Packaging and Transportation | 1 min 09 secs |
Enzyme Analysis Systems Validations – Packaging and Transportation | 1 min 45 secs |
Programming Software | 1 min 33 secs |
Device Software | 1 min 11 secs |
Reporting Software | 1 min 05 secs |
Conclusion
Final Assessment
Certification
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