Monday 27 November 2017

Risk Based Approach to Environmental Monitoring (webinar)

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.

Instructor: Tim Sandle
Product ID: 504486

Date: Tuesday, 19 December 2017 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes
  • 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 investigationsWhy 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 engineer
For details se: Online Compliance

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