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Welcome to this short introduction to the contents of the presentation on Effective Medical Device Validation http://www.PresentationEze.com This presentation provides information on • the contents of the Presentation – Section A (Pgs 2 – 23) • ordering, cost & product delivery details – Section B (Pgs 24 – 26)
Section A (i) – Medical Device Validation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Section A (ii) – Creating Compliant Validations ,[object Object],[object Object],[object Object]
Introduction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Requirements and International Standards ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Medical Devices ,[object Object],[object Object],[object Object],[object Object],[object Object]
Approaches to Process Validation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Approach to Software Validation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Design Control: Design Input & Design Output. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Life Cycle Approach to Validation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Life Cycle Approach to Validation continued. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documentation ,[object Object],[object Object]
Revalidation ,[object Object],[object Object],[object Object]
Master Validation Plan (VMP) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Validation Gap Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Based Approach to Validation Planning ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other Validations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Protocol Reporting ,[object Object],[object Object],[object Object],[object Object],[object Object]
Auditing ,[object Object],[object Object],[object Object],[object Object],[object Object]
When is a Process Considered Validated ,[object Object],[object Object],[object Object]
Example FDA related warning letters ,[object Object],[object Object],[object Object]
Creating compliant Validations – Quality Tools and Statistics Quality Improvement Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Creating compliant Validations – Quality Tools and Statistics Statistical Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Section B - Ordering and Cost ,[object Object],[object Object],[object Object],[object Object],[object Object]
Section B - Product delivery details ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Product delivery details, continued. ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],PresentationEze.com

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Effective medical device validation introduction manual advance

  • 1. Welcome to this short introduction to the contents of the presentation on Effective Medical Device Validation http://www.PresentationEze.com This presentation provides information on • the contents of the Presentation – Section A (Pgs 2 – 23) • ordering, cost & product delivery details – Section B (Pgs 24 – 26)
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