The Lean Microbiology Laboratory - A New Approach to Environmental Monitoring

Duration: 60 Minutes
A lean laboratory is one which is focused on processes, procedures, and infrastructure that deliver results in the most efficient way in terms of cost, speed, or both. Lean laboratory is a management and organization process derived from the concept of lean manufacturing. This webinar looks at how lean principles can be applied to assessing contamination risks and for reviewing the environmental monitoring program. This includes a determination as to whether samples are suitable and outlining a methodology for a risk-based approach to sample reduction.
Lean Microbiology Laboratory
Instructor: Tim Sandle
Product ID: 508969
Objectives of the Presentation
  • General introduction to lean labs
  • Focus is on cleanrooms and equipment within cleanrooms
  • Introduction to risk assessment
  • Microbiological risks
    • Case studies that illustrate examples of key concepts:
    • HACCP and selection of EM locations
    • FMEA to pin-point process risks
    • Lean manufacturing to reduce sample locations
Why Should you Attend
An essential part of lean in the laboratory is to manage and review a lab's performance daily, ensuring that Key Performance Indicators (KPI's) are good and that the overall laboratory process is in control. One area to which these principles can be applied to is environmental monitoring. The webinar illustrates this through the use of a case study.

Areas Covered
  • Lean labs
  • 5s considerations
  • Environmental monitoring sample selection
  • FMEA approach to risk analysis
  • Environmental monitoring sample reduction
  • Microbiological risks
  • Contamination control
  • Data trending
Who will Benefit
  • Quality managers
  • Quality assurance
  • Microbiologists
  • Production staff
  • Senior managers in pharmaceuticals and healthcare
Topic Background
Pharmaceuticals and healthcare facilities are increasingly focusing on lean ways of working, as to drive value for money from processes. A dilemma for the microbiology laboratory is with how to appropriately assess risks and to ensure that sampling remains appropriate to detect contamination events, while meeting lean principles. This webinar assess microbial risks using risk assessment schema and then presents a case study to illustrate how lean principles can be applied to the environmental monitoring of cleanrooms and controlled environments.
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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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