How to justify doing less microbiological sampling and testing, and still pass a regulatory inspection

Duration: 60 Minutes
This presentation is about environmental monitoring, considering why we perform environmental monitoring and how a value added program can be constructed. This is a program that delivers appropriate information at the right frequency which can be reviewed by microbiologist, quality assurance and production personnel. The focus is developing risk based thinking and evaluating what actually takes place within different types of cleanrooms. This approach involves assessing a range of different factors relating to cleanroom design, use, control parameters, product exposure, operators and so on.
Environmental Monitoring
Instructor: Tim Sandle
Product ID: 507083
Objectives of the Presentation
  • The importance of environmental monitoring
  • The application of risk assessment
  • Understanding appropriate monitoring frequency
  • How to perform a detailed analysis of room use
  • Applying quantitative risk assessment
  • Applying risk filtering
  • Learning how to review an environmental monitoring program and to ensure that it is fir for purpose
Why Should you Attend
To gain an understanding of the requirements of environmental monitoring and how to develop a risk based program which is value added, where sampling locations and, in particular, frequencies of monitoring have been appropriately considered, rationalized, implemented and effectively checked.

Areas Covered
  • How to select and apply the most appropriate risk assessments
  • Mechanisms of contamination transfer
  • Contamination risk factors for cleanrooms
  • How to assess risks relating to cleanrooms of different classes and used for different activities
  • How to evaluate the relative risks of different cleanrooms
  • Worked examples for risk modeling
  • Assessing how cleanroom risks can change over time
  • Process flows and environmental monitoring sample selection
Who will Benefit
  • Microbiologists
  • Quality assurance
  • Quality control
  • Production management
  • Senior managers
  • University professors
Topic Background
Environmental monitoring represents an important part of the biocontamination control strategy. However, many monitoring regimes are not risk based. By applying risks assessment regimes can be configured so they are 'fit for purpose' and used to actually generate meaningful data. The risk based approach may also result in less monitoring being undertaken, or monitoring re-directed from areas of a lower risk to a higher risk. This can be undertaken by assessing the frequencies of monitoring and reviewing different contamination risks within cleanroom environments. This requires the application of tools like risk ranking and risk filtering, which this webinar will address through a series of worked examples.
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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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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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