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Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment
Date & Time:
Thursday, October 27, 2011 10:00 AM PDT | 01:00 PM EDT

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Duration: 60 Minutes Location: Online

Instructor: Rudy Pina Price : $245.00

(for one participant)

Instructor Profile:

Overview:
A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring. Recommended selection of sampling sites will be covered. An overview of different types of potential microorganisms that can be encountered will be discussed. A pattern of a Potential Historical Contamination Trend will be discussed.

Rudy Pina Lab Director, Dynatec Scientific Labs Rudy Pina has over 30 years of experience in The Medical Device Industry. He has worked for American Hospital Supply, Baxter Healthcare. Rudy is President of Dynatec Scientific Laboratories Inc. Rudy is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Working Group. Member of FDA/Industry Coolition - Dallas District Office Member of NAFTA Trilateral Negotiations - Medical Technology Sector....more

Why you should attend:

The attendee will be given a summary of test methods and, in addition, a brief overview of which methods to select based on scientific documentation. The attendee will be given information related to appropriate and relevant standards in order to assist in the development or update of current monitoring programs. Finally, the attendee will be given a glimpse into the types of microorganisms and their environmental source that can exist in a cleanroom and subsequently, on your product. You should attend in order to ensure your current system is adequate or learn how to develop a new monitoring system.

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Areas Covered in the Session:

Definition of a Cleanroom, Clean Zone Monitoring Systems n Air Sampling Active Passive Surface Sampling
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Contact Plates Swabs Personnel Monitoring How to identify contamination sites

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Gowns Hands n Aerosol Sampling Methods

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Contact Plates Bioburden Extraction 11737 Compressed Air Slit to Agar

Establish sampling Plain Select Appropriate Sites Parental - U.S.P. <1116> n Container Path of opened container Compressed Air (Impact on Product) Device n Assembly Line
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Packaging Storage/ Warehouse n Compressed Air Microbiological Characterization (Based on)

Unique Flora Regional Finger Print

Equipment & Personnel Water System Seasonal Trends Cleanroom Classification

Method of Analysis DNA Sequences

Biochemical Analysis Fatty Acid profiling

Microbiological Flora/ Seasonal Trend

Click here to register for this webinar Who Will Benefit:

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Quality Manager Sterility Assurance Manager Quality Engineer Sterilization Engineer Regulatory Affairs Manager Infection Control Specialist

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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