ComplianceOnline

Environmental Monitoring and the Contamination Control Plan

Instructor: Scott Sutton
Product ID: 701241
  • Duration: 95 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2010

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

Environmental monitoring is a useful tool to demonstrate the state of control of the facility, but it is not a measure of the finished product quality. This presentation will focus on how to use the EM data appropriately as part of a contamination control plan. It will explain the requirements of Regulatory requirements as per USP, FDA, EU and EMEA. Along with Scott Sutton will discuss how to Design and Manage a Microbiological Monitoring Program. What are the components of and the execution of The Contamination Control Plan will be discussed.

Areas Covered in the Seminar:

  • Regulatory Expectations for EM will be examined using guidance from US, Europe and PIC/S.
  • Cleaning/Disinfection must be validated, and then shown to be effective on an on-going basis.The EM program can be used effectively to demonstrate the adequacy of the sanitization schedule.
  • The Contamination Control Plan might be the single most important document never written. While this is sometimes present as the "Sterility Assurance" plan, more often no comprehensive plan exists for the facility.Components of the document and its execution will be addressed.
  • Designing and Managing a Microbiological Monitoring Program - this will include surface, active air, passive air, utilities and personnel monitoring.
  • Considerations in Trending EM Data - suggestions on different types of trending approaches will be provided.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies (Pharma, medical device, biotech, OTC etc) that need to the employees who will benefit include:

  • End-users responsible for finished product testing
  • QA managers and personnel
  • Consultants
  • Quality system auditors

Instructor Profile:
Scott Sutton, Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). After a NIH postdoctoral fellowship he worked for Bausch and Lomb until 1994 when he went to Alcon Laboratories, and in 2004 accepted a position with Vectech Pharmaceutical Consultants. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. Dr. Sutton also operates an information source on the internet, The Microbiology Network (http://www.microbiol.org) which provides services to microbiology-related user’s groups and supports the PMFList, a microbiology Email list (http://www.microbiol.org/pmflist.htm) and the PSDG Email list (pharmaceutical stability topics) (http://www.microbiol.org/psdglist.htm).

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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

This would be a tool for a good basic understanding of an environmental monitoring program.(Microbiologist II Boehringer Ingelheim Vetmedica, Inc.)
- Kim Clements

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