Process Validation for Medical Devices

Early Registration Discount
Early registration until March 16, 2020
Registration from March 17, 2020
1,750 NIS + VAT
Lecturer: Mr. Gadi Shtepel

Date: 26 March 2020
Location: Leonardo Boutique Rehovot Hotel
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,750 NIS + VAT
Credit Points: 1
SKU: 20652
Course Language: Hebrew
About the Course
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Who should attend
TBA
Process Validation for Medical Devices
Benefits to the Participants
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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

Mr. Gadi Shtepel

Gadi Shtepel brings with him over 35 years of experience in the fields of Quality Assurance and Regulatory Affairs- the last 15 years in the Medical Device industry.
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