Process Validation for Medical DevicesProcess Validation for Medical Devices

Conducted by: Mr. Gadi Shtepel
SKU: 20652
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Date:  26 March, 2020
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪1,850 + 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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