How to Investigate Environmental Monitoring Excursions

Why Should You Attend:

Medical products are manufactured in environments that are designed to control the level of viable and non-viable particulate and these environments must be monitored to establish that the control measures are continuing to perform acceptably including the impact to product bioburden. You need to establish appropriate levels for ongoing monitoring, so it is critical that you know how to set these levels. But once these levels have been set it is also critical for you to know what actions should be taken to determine if there is product impact or other implications to the manufacturing process when the monitoring results exceed these defined levels.

This presentation will review best practices for setting bioburden or environmental monitoring levels and the various items that should be included in an investigation to determine the cause of both viable and non-viable excursions. It will provide guidance on how to determine who, what, when, where so that you can figure out the how and why, i.e., root cause. It will also provide guidance on how to write your investigation story so that manufacturing and regulatory bodies will be able to follow the investigation coming to the same how and why that you did.

Areas Covered in the Webinar:

• Best practices for monitoring and establishing limits.
  • Product bioburden
  • Viable particulate
  • Non-viable particulate
• Do I really need to investigate if the alert levels are exceeded?
• Investigating an alert level excursion.
  • In the environment
  • On the product
• Who to investigate.
• What to investigate.
• When - what is the appropriate timeline to investigate.
• Where should you look.
• Documenting the investigation story.

Who Will Benefit:

This webinar will provide valuable information to all companies that manufacture medical products in environments that are controlled and monitored for viable or non-viable contamination.

• QA personnel
• Manufacturing
• R&D

Gerry O Dell
President, Gerry O’Dell Consulting

Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.

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