How To Investigate Environmental Monitoring Excursion Limits

Why Should You Attend:

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 limits for ongoing monitoring so it is critical that you know how to set these limits. But once these limits have been set it is also critical for you to know what actions need to be taken to determine if there is product impact or other implications to the manufacturing process when the monitoring results exceed these defined limits.

This presentation will review best practices for setting bioburden/environmental monitoring limits and the various items that should be included in an investigation to determine the cause of a limit excursion for both viable and non-viable excursions. It will provide guidance on how to determine the who, what, when, where so that you can figure out the how and why. 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 Seminar:

Best practices for monitoring and establishing limits.

- Product bioburden

- Viable particulate

- Non-viable particulate

Do I really need to investigate if the alert limits are exceeded?

Investigating an alert limit 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 devices in environments that are controlled and monitored for viable or non-viable contamination.

- QA personnel

- Manufacturing Supervisors

- R&D

Instructor Profile:

Gerry ODell, is President of Gerry ODell Consulting, a consulting firm based in the United States with clients around the world. Gerry ODell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance.

Prior to starting Gerry ODell 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-five years of experience in the medical device industry.

by: ComplianceOnline

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