Risk Management and Environmental Monitoring

December 2nd, 2021

11:00 AM – 12:00 PM EDT

Environmental monitoring and risk management are two critical elements in Quality Systems Management – both the EM environment and using risk in process are equally scrutinized by FDA and other regulatory agencies. This webinar shows you how to merge these two concepts into one seamless process. Attend this tutorial and learn:

Part 1 – Environmental Monitoring and Why Risk-Based EM

  • Review and understand regulations and guidance documents involving environmental monitoring
  • Understand environmental monitoring across various industries (i.e. medical device, cosmetic, OTC, pharmaceutical)
  • Understand the reasoning for risk-based environmental monitoring
  • Plan for a risk assessment and obtaining “buy-in”

Part 2 – Completing Environmental Monitoring Risk Assessments and Trending

  • Review and understand multiple risk assessment methodologies by working through examples
  • Understand the reasoning for data trending in environmental monitoring
  • Overview of different data trending methods that may be used

Knowledge Exchange

  • Review of environmental monitoring and discussion of its extent across various industries
  • Work through examples of environmental monitoring risk assessments
  • Discuss trending of environmental monitoring and its importance

Takeaway Tools

  • Templates for environmental monitoring risk assessments.

SPEAKERS


Cecil Runyon

Senior Director, Azzur Labs


With over 17 years’ experience in the medical device, cosmetic and pharmaceutical industries, Cecil Runyon has specialized in laboratory development and operations, environmental monitoring program development and contamination investigation and control for both laboratories and manufacturing. He has experience with FDA, EU and other rest of world regulations for various types of laboratories and production environments. As a Senior Director for Azzur Labs, Cecil is responsible for the development and operations of the Azzur Labs Chicago location. Cecil has a BS in Biological Sciences from Eastern Illinois University and an MBA from Lake Forest Graduate School of Management. His career has involved microbiological and analytical method development and testing, laboratory design and development, development and control of various environmental monitoring programs, performing contamination investigations for multiple laboratories and manufacturers, new product development, continuous improvement and multiple aspects of QMS. Cecil is a Registered Microbiologist through the American Society for Microbiology (ASM), as well as an active member in ASM and the Illinois Society of Microbiology.