An Introduction to Medical Device Validation – Part 3


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:
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
Final Assessment

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