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Risk Based Approach to Environmental Monitoring - Webinar


2017, December 19

Pharmaceutical » 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.

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

Visit www.onlinecompliancepanel.com


Venue

Internet - webinar

Organizer

Online Compliance Panel
Phone: -7,262
Email: webinar@onlinecompliancepanel.com
Visit organizer website



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