Manufacturing Process Validation for Medical Devices
Online Course Course

Manufacturing Process Validation for Medical Devices

  • Dates 27 June 2024
  • Location Zoom
  • Hours 6 hours
  • Language English
  • Hours 15:00-21:00 Brussels
  • 14:00-20:00 UK
  • 09:00am-03:00pm New York
$700 Until 28 Apr 2023
$780 Until 20 Jun 2024
$900 Until 27 Jun 2024
About the Course
Gadi Shtepel
Lecturer: Gadi Shtepel
Gadi brings with him over 30 years of experience in the fields of Quality Assurance and Regulatory Affairs in the Medical Device companies.
Gadi held some key positions in the Medical Device Industry for devices under the FDA and EU regulations and was a Lead Auditor for a leading EU Notified Body.
Gadi holds a B.Sc in Engineering from the Techinon - The Israeli Institute of Technology.

Manufacturing Process Validation is a mandatory regulatory requirement for Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Process Validation.  The Process Validation maps all manufacturing processes and identifies those which must be validated. For these processes Validation Protocols and Reports are prepared documenting the evidence for the capability of these processes.

During this course the topics of Process Validation will detailed including effective methods and tools.


  • Regulatory Requirements
  • Definitions
  • When is validation required?
  • Process Development and Optimization
  • Statistical Aspects of Process Validation
  • Risk Management (פFMEA)
  • 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 Examples

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