Wednesday 22 August 2018

ISO 14644 - The Revised Standard and Implications for Cleanrooms (webinar)

The international standard for cleanrooms has undergone a major revision. This webinar discusses the revisions in the context of global GMPs and the overall contamination control strategy. The webinar discusses testing approaches and the assessment of test data. The learning point is with keeping cleanrooms compliant.

New webinar - Date: Thursday, 30 August 2018 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes

  • How to assess a cleanroom as built, at rest and in operation
  • How cleanroom standards inter-link to global GMPs
  • How to evaluate cleanroom data
  • How to assess cleanroom contractors
  • The importance of a risk based approach
  • Assessing microbial and particulate risks
This presentation will review the changes to ISO 14644 Parts 1 and 2 and will focus on the factors to consider when performing your risk assessment and creating your monitoring plan. How do justify sampling locations for classification? How often are you going to perform period reclassification? What about the other ancillary cleanroom testing required in ISO 14644-3? How often will you perform that based on risk? What items should you include in your monitoring plan document? Changes to these ISO standards will impact the way you perform cleanroom classification activities. Everything you need to know to be compliant to the changes.

See: Online Compliance Panel (

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

No comments:

Post a Comment

Pharmaceutical Microbiology Resources

Special offers