Clean Room Control, Validation & Monitoring for Medical Devices
Online Course Course

Clean Room Control, Validation & Monitoring for Medical Devices

  • Dates 08 July 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 08 May 2023
$780 Until 28 Jun 2024
$900 Until 08 Jul 2024
$900
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.

Clean Room Control is a mandatory regulatory requirement for Terminally Sterilized Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Clean Room Control.  Some manufacturing activities of Terminally Sterilized medical devices must be performed in a controlled environment (clean room) T controlled Environment needs to be initially qualified and continuously monitored.

During this course the topics of Clean Room Control, Validation & Monitoring will detailed including effective methods and tools.

Content:

  • Regulatory Requirements
  • Definitions
  • Classification (Non-viable & Viable)
  • Documentation- SOPs
  • Initial Qualification (Validation)
  • Ongoing Monitoring (periodic)
    • Physical
    • Non-viable Particulate
    • Microbial (EN 141710)
  • Cleaning & Maintenance
  • Personnel Gowning
  • Re- Qualification

 

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