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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