ecowebinar.com Open in urlscan Pro
108.179.234.144  Public Scan

Form analysis
2 forms found in the DOM

POST

<form action="" method="POST">
  <div class="row g-3">
    <div class="col-md-6">
      <label for="your-name" class="form-label">First Name </label>
      <input type="text" class="form-control" id="your-name" placeholder="Enter First Name" name="fname">
    </div>
    <div class="col-md-6">
      <label for="your-surname" class="form-label">Last Name </label>
      <input type="text" class="form-control" id="your-surname" placeholder="Enter Last Name" name="lname">
    </div>
    <div class="col-md-6">
      <label for="your-email" class="form-label">Email Id <b class="treqired">*</b></label>
      <input type="email" class="form-control" id="your-email" placeholder="Enter Email" name="email" required="">
    </div>
    <div class="col-md-6">
      <label for="your-subject" class="form-label">Phone Number <b class="treqired">*</b></label>
      <input type="text" class="form-control" id="your-subject" placeholder="Enter Phone Number" name="contact" onkeypress="return event.charCode >= 48 &amp;&amp; event.charCode <= 57" required="">
    </div>
    <div class="col-md-6">
      <label for="your-message" class="form-label">Preferred Date &amp; Time <b class="treqired">*</b></label>
      <input type="datetime-local" class="form-control" id="datatime" required="" name="preferredtime">
    </div>
    <div class="col-md-6">
      <label for="your-message" class="form-label">Your Query <b class="treqired">*</b></label>
      <textarea class="form-control" id="your-message" name="message" rows="3" required=""></textarea>
    </div>
    <div class="col-md-12">
      <span>&nbsp;</span>
    </div>
    <div class="col-12" style="text-align: center;">
      <button type="submit" style:"margin-top:50px;"="" class="btn btn-dark" name="callbackrequest">Send Request</button>
    </div>
  </div>
</form>

POST

<form action="" method="POST"></form>

Text Content

 * Home
 * About
 * + 1 (866) 755-8624
 * Login
 * Register
 * 0
 * Request Callback

×

REQUEST CALLBACK

First Name
Last Name
Email Id *
Phone Number *
Preferred Date & Time *
Your Query *
 
Send Request

GMP ENVIRONMENTAL MONITORING FOR PHARMACEUTICAL CLEAN ROOMS 2024




 Date : Thursday Apr 25, 2024  Presented By : Roger Cowan  Time : 1:00 PM EDT
 Event Type : Live Webinar  Duration : 60 minutes  Event Category :
Pharmaceutical  Days Left : 1 Days  Order Form : Order Form

For group or any booking support, contact:  cs@ecowebinar.com  + 1 (866)
755-8624 (US Toll Free)


Live $229 Recording $229 Transcript $229 DVD $249 Live & Recording $399
Recording & Transcript $399



DESCRIPTION

Environmental Monitoring looks at the end results of the Environmental Control
program – the microbiological and particulate quality of the clean room.

As the FDA Guideline on Aseptic Processing GMP (2004) states:

“In aseptic processing, one of the most important laboratory controls is the
environmental monitoring program. This program provides meaningful information
on the quality of the aseptic processing environment (e.g., when a given batch
is being manufactured) as well as environmental trends of ancillary clean areas.
Environmental monitoring should promptly identify potential routes of
contamination, allowing for implementation of corrections before product
contamination occurs.”

Therefore, ongoing environmental monitoring of a clean room environment is
necessary to assure the quality and safety of the pharmaceutical product. Also,
a proper understanding and testing of the clean room environment according to
international regulatory standards is important from a compliance perspective.


AREAS COVERED:-

 * GMP Compliance of Clean Room Environment
 * Regulatory Clean Room Classification and Requirements
 * Environmental Monitoring Program
 * Action and Alert Levels
 * Non-Viable Particulate Monitoring Systems
 * Microbial Monitoring Systems
 * Personnel Gowning and Aseptic Practices in Clean Room
 * Clean Room Monitoring Practices - Frequency, Locations, and Investigations
 * Product Release
 * Environmental Monitoring Data Trend reports


WHY SHOULD YOU ATTEND:-

This webinar first explains the various US and international regulatory
requirements for the various cleanroom classifications as well as the
environmental monitoring of cleanroom environments. Next, the presentation
details the benefits, the regulatory requirements, and the testing requirements
for a comprehensive Environmental Monitoring Program.

A description of Action and Alert Levels follows along with a discussion of how
these levels are determined for a particular facility.  Corrective and
Preventative Actions are defined.

All current air monitoring systems for the measurement of non-viable particulate
are fully reviewed.

All current air and surface monitoring systems for the measurement of microbial
contaminants in the clean room are discussed in detail.

The subject of clean room contamination due to personnel is discussed.  This
includes both the gowning technique and aseptic practices.

Ongoing monitoring practices for the clean room environment are discussed with
respect to the sampling frequency, sampling locations, and the investigation of
action-level excursions.

This is followed by a discussion of how environmental monitoring data is
reviewed for product release.

Finally, a comprehensive look is taken at the current thinking about
the generation and review of Environmental Monitoring Data Trend Reports.


WHO WILL BENEFIT:-

This webinar will provide valuable assistance to all personnel in:

 * Quality Assurance
 * Environmental Monitoring
 * Microbiology
 * Manufacturing
 * Validation
 * Engineering
 * Maintenance

PRESENTED BY : ROGER COWAN

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a
consulting company specializing primarily in pharmaceutical contract
manufacturing. He has 35 years of experience in pharmaceutical quality assurance
and manufacturing. In his career, Roger has held various manager/director
positions in Quality Assurance, QC Laboratory, Technical Services Validation,
Manufacturing, and Clinical Supply manufacturing and distribution. Roger has
taught courses in microbiology at Seneca College (Pharmaceutical Technology
Program) in Toronto, Canada.   

Roger's areas of expertise include aseptic pharmaceutical manufacture, GMP
facility audits, technical transfer, microbiology, environmental
monitoring/contamination control, product sterilization, process development,
process validation, clinical supply manufacturing, labeling and distribution, US
/ International regulatory requirements, regulatory submissions, and quality
assurance/control.


FIND MORE PHARMACEUTICAL WEBINARS

Show 102550100 entries
Search:

EventCategorySpeakerDeatils No data available in table

Showing 0 to 0 of 0 entries
PreviousNext


   COMPANY DETAILS

   
 * Terms & Condition
 * Privacy Policy
 * Refund Policy
 * FAQ
 * Contact us


   USEFUL LINKS

 * Unsubscribe
 * Speaker Opportunity
 * Suggest Topic
 * Join our Mailing List
   
 * Presenter


   USEFUL LINKS

 * Copyright 2024 ecowebinar . All Rights Reserved.

 * All Logos and Trade Marks on the website are property of their respective
   owner.

FIND US

--------------------------------------------------------------------------------

1430 Gadsden Hwy Ste 116-1026 Birmingham,
AL 35235 United States

CALL US

--------------------------------------------------------------------------------

+ 1 (866) 755-8624

MAIL US

--------------------------------------------------------------------------------

cs@ecowebinar.com