Risk Based Approach to Environmental Monitoring

Date: Tuesday, 19 December 2017 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes
Regulators frequently cite concerns with environmental monitoring and the lack of a well-thought out rationale. This shortfall can be overcome through the application of risk assessment and scientific approaches. The application of risk assessment applies to selecting location for monitoring and frequencies of monitoring; and for data assessment. This presentation outlines the primary tools that can be used to achieve this.
Risk Based Approach to Environmental Monitoring
Instructor: Tim Sandle
Product ID: 504486
Objectives of the Presentation
  • Understanding what environmental monitoring sets out to show, in relation to environmental control
  • Appreciating the limitations of monitoring
  • Understanding risk assessment tools like FMEA and HACCP and how they can be applied to environmental monitoring
  • Worked examples of how to apply risk based approaches for setting monitoring frequencies
  • Worked examples of how to apply risk based approaches for determining monitoring locations
  • Understanding how risk assessment can assist with out-of-limits investigations
Why Should you Attend
To understand different approaches for environmental monitoring through the adoption of risk based methodologies. These tools can either be applied to the workplace or used to benchmark current practice against. The approaches discussed have been presented to FDA and European medicines inspectors.

Areas Covered
  • An overview of environmental monitoring and a biocontamination control strategy
  • Discussion of environmental monitoring methods
  • Introduction to risk concepts, hazard identification and risk assessment
  • Introduction to FMEA
  • Introduction to HACCP
  • Application of risk tools to elements of the environmental monitoring program, such as assessing contamination risks, setting monitoring frequencies, assessing monitoring locations
  • How to determine if too little or too much monitoring is being undertaken
Who will Benefit
  • Microbiologists (QA and QC)
  • QC managers
  • Production managers
  • Quality Assurance personnel
  • Cleanroom engineers
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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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