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.
12/19/2017 10:00 AM12/19/2017 04:00 PMTraining Topic: Risk Based Approach to Environmental MonitoringInstructor: Tim Sandle
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.
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
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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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