clean room microbial load and characterization of microorganisms inthe clean room environment

2
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

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A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed.

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Page 1: Clean Room Microbial Load and Characterization of Microorganisms inthe Clean Room Environment

   

 

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

 

Page 2: Clean Room Microbial Load and Characterization of Microorganisms inthe Clean Room Environment

¡ 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

About GlobalCompliancePanel

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