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speciality

cleanroom requirements according to ISO 14644 series (steam201909-clone)


Description
This training is designed for an understanding of the ISO 14644-1 requirements and subsequent parts for sterile medical devices and compliance with MDR and MDD.
This 1 day training provides you with a complete understanding of the requirements and includes study cases.
Content
  • Introduction-Module 1
  • cleanroom introduction
  • Classification of cleanroom-Module 2
  • classification cleanrooms
  • control of contamination- Module 3
  • control of contamination
  • setting up a cleanroom-Module 4
  • setting up cleanroom
  • example of cleanroom project plan
  • Difference of pressure
  • Validation of cleanroom-Module 5
  • validation report
  • example of validation protocol
  • example of report
  • validation report
  • cleanroom monitoring- Module 6
  • monitoring test
  • cleanroom in operations-Module 7
  • example of gowning procedure
  • cleanroom in operations
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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