An Introduction to Medical Device Validation – Part 3
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 01 secs |
Who Should Take This Course? | 1 min 21 secs |
Module 1: The Starting Point
Introduction to Non-Product Validations | 1 min 05 sec |
What We Will Cover? | 1 min 10 secs |
Module 2: Non-Product Validation Program
Validation Master Plan | 1 min 12 secs |
Risk Matrix | 1 mins 29 secs |
Individual Validation Plan | 1 min 02 secs |
Individual Validation Plan – Validated State | 1 min 25 secs |
Protocol Construction | 1 min 10 secs |
Results | 1 min 38 secs |
Test Failures and Issues | 1 min 30 secs |
Reporting | 1 min 11 secs |
Validation Toolbox | 1 min 14 secs |
Module 3: Overview of Typical Protocols
Design Qualification (DQ) | 1 min 01 secs |
Installation Qualification (IQ) | 1 min 13 secs |
Operational Qualification (OQ) | 1 min 33 secs |
Don’t Forget About Requirements! | 1 min 06 secs |
IQ, OQ, PQ or…? | 1 min 19 secs |
Module 4: Introduction to Process Validation
Process Validations | 1 min 10 secs |
Process Validation Considerations | 1 min 01 secs |
Types of Process Validations | 1 min 25 secs |
Validation Approach Tradeoffs | 1 min 09 secs |
Process Validation Example – Printed Circuit Board | 1 min 45 secs |
Installation Qualification (IQ) | 1 min 33 secs |
Requirements & Operational Qualification (OQ) | 1 min 11 secs |
Performance Qualification (PQ) | 1 min 05 secs |
Potting (IQ, OQ, PQ) | 1 min 40 secs |
Oven (IQ, OQ, PQ) | 1 min 09 secs |
Other Validations That Need To Be Considered – Part 1 | 1 min 16 secs |
Other Validations That Need To Be Considered – Part 2 | 1 min 39 secs |
Module 5: Other Validation Considerations
Validation is a State, NOT an Event! | |
Intended Use | |
Additional Considerations |
Conclusion
Final Assessment
Certification
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