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

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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. [/av_textblock] [/av_three_fourth][/av_section]

October 5, 2021/by John Tocci

Environmental Monitoring:
A Contamination Control Tool

November 2nd, 2021 11:00 PM – 12:00 AM EDT

November 3rd, 2021 11:00 AM – 12:00 PM SST

The draft revision to EudraLex Annex 1 emphasizes the importance of a well-defined contamination control strategy. Environmental monitoring (EM) is an essential component of a site’s contamination control toolkit. In this webinar, we will discuss what EM does (and doesn’t do), and how to develop or refine an EM program to achieve a well-rounded contamination control strategy. This webinar is ideal for quality assurance, quality control, and manufacturing personnel seeking to understand how EM fits into a contamination control strategy, to learn how to data-mine from an EM program, and to identify improvement opportunities.

Top Five Benefits

Learn the purpose of EM, and the role EM does and does not play in the contamination control
Understand the impact of room cleaning on contamination control
Understand the importance of personnel in a controlled environment, from aseptic behavior to gowning to interventions
Identify potential red flag practices with the aid of real-world examples
Learn how to use your EM program to identify and control sources of contamination

SPEAKERS

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Elizabeth Brockson

Associate Director, Global Quality Control, CAI

Elizabeth Brockson has a background in benchtop microbiology and immunology, as well as over 7 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. She is currently a consultant with Commissioning Agents, Inc. Her roles have included microbiology, auditing, and compliance/regulatory as they pertain to global regulations including FDA, MHRA, and Health Canada. [/av_textblock] [/av_three_fourth][/av_section]

January 7, 2021/by Jonathan Driscoll

Archive for category: Webinar

Risk Management and Environmental Monitoring

SPEAKERS

Environmental Monitoring: A Contamination Control Tool

Top Five Benefits

SPEAKERS

Elizabeth Brockson

Environmental Monitoring:
A Contamination Control Tool