How to Investigate Environmental Monitoring Excursions Limits

Speaker

Instructor: Gerry O Dell
Product ID: 701504

Location
  • Duration: 60 Min
This environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs.
RECORDED TRAINING
Last Recorded Date: Feb-2013

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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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 Webinar:

  • 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 O'Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell 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 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-five years of experience in the medical device industry.

Gerry is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in the Sterilization Standards Committee activities. She is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the Sterilization Residuals, Radiation Sterilization, Sterility Assurance Level (SAL), Compatibility of Materials Subject to Sterilization, and Microbiological Methods Working Groups; actively participating in the development of several standards and guidance documents. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. She is also a member of theAmerican Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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