Process Validation for Medical DevicesProcess Validation for Medical Devices

Conducted by: Mr. Gadi Shtepel
SKU: 20652
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Date:  26 March, 2020

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    Course location: Kfar Maccabiah, Ramat Gan
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: עברית

    Course price: €524 + VAT
    Early registration is Closed
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    Issues to be covered

    • Process Validation for Medical Devices
    • Regulatory Requirements
    • Definitions
    • When is validation required?
    • Process Development and Optimization
    • Statistical Aspects of Process Validation
    • Risk Management – PFMEA
    • Test Method Validation – TMV
    • Process Validation Master Plan – PVMP
    • Installation Qualification – IQ
    • Operational Qualification – OQ
    • Performance Qualification – PQ
    • Process Validation Protocols & Reports
    • Maintaining State of Validation and Re-Validation
    • Retrospective Validation
    • Process Validation Example

    About The Lecturer

    Gadi Shtepel
    Gadi Shtepel brings with him over 35 years of experience in
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    תחזוקת מערכת האיכות בזמן מלחמה QMS

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