ISO 14644 - The Revised Standard and Implications for Cleanrooms

Duration: 60 Minutes
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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.
ISO 14644
Instructor: Tim Sandle
Product ID: 509318
Objectives of the Presentation
  • 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
Why Should you Attend
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.

Areas Covered
  • Introducing cleanroom standards
  • How the new standard differs
  • How to risk assess cleanrooms
  • How to interpret data
  • How to select cleanroom contractors
  • How cleanroom data fits into the overall contamination control strategy
Who will Benefit
  • Production and manufacturing
  • Quality assurance
  • Quality control
  • Microbiology
  • Engineering
  • Regulatory personnel
$375
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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