clean room microbial load and characterization of microorganisms inthe clean room environment
DESCRIPTION
A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed.TRANSCRIPT
Live Webinar on
Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment
Date & Time:
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.
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.
l Definition of a Cleanroom, Clean Zone
¡ Monitoring Systems
n Air Sampling
n Active
n Passive
n Surface Sampling
n Contact Plates
n Swabs
n Personnel Monitoring
n How to identify contamination sites
n Gowns
n Hands
n Aerosol
n Sampling Methods
n Contact Plates
n Bioburden Extraction 11737
n Compressed Air
n Slit to Agar
l Establish sampling Plain Select Appropriate Sites
¡ Parental - U.S.P. <1116>
n Container
n Path of opened container
n Compressed Air (Impact on Product)
¡ Device
n Assembly Line
n Packaging
n Storage/ Warehouse
n Compressed Air
l Microbiological Characterization (Based on)
¡ Unique Flora
¡ Regional Finger Print
Thursday, October 27, 2011 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes Instructor: Rudy Pina
Location: Online Price : $245.00 (for one participant)
Overview:
Why you should attend:
Areas Covered in the Session:
Register Now
Instructor Profile:
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
Rudy Pina
Lab Director, Dynatec
Scientific Labs
Suggest a Topic More Webinars
Your Necessity is our Priority
¡ Equipment & Personnel
¡ Water System
¡ Seasonal Trends
¡ Cleanroom Classification
l Method of Analysis
¡ DNA Sequences
¡ Biochemical Analysis
¡ Fatty Acid profiling
l Microbiological Flora/ Seasonal Trend
Click here to register for this webinar
l Quality Manager
l Sterility Assurance Manager
l Quality Engineer
l Sterilization Engineer
l Regulatory Affairs Manager
l Infection Control Specialist
Who Will Benefit:
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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