Gaining and Re-establishing Control of your Clean Room

  • Speaker:Joy McElroy
  • Date: 27th February 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90236

$279

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Live Session - How it works

  • Username and Password will be emailed to you within 24 hours prior to the date of the webinar.
  • Presentation handouts in pdf format will be emailed to you along with the login instructions.
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  • Get answers to your questions through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions. You can also type in your questions using Chat box in the meeting window.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you haven't received an email within 6 working days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to access the webinar recording will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is valid for 6 months.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD/ USB - How it works

The order will be processed within 2 working days from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products and services please contact our support team by email support@grcts.com or call us at +1 (248) 233-2049.)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

Description:
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.

Objective:
Upon completing this course participants should:

  • The critical steps needed to release the room for manufacturing will be discussed. 
  • Routine cleaning and disinfection strategies will be covered as well as the latest in equipment and application. 
  • Establishing control of the clean room after a worst case event. 
  • Excursion events will be discussed and case studies will be covered regarding excursion events.
Outline:
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
  • Critical steps in starting a new clean room operation
  • Critical Steps need to release the clean room for manufacturing
  • Routine cleaning and disinfection strategies
  • Utilities
  • Contamination
  • Environmental monitoring
  • Establishing control of the clean room after a worst case event
  • Excursion events
  • Case studies regarding excursion events
  • Excursion investigations and troubleshooting parameters
  • Questions
Target Audience:
This 90 minute webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs, including companies in the pharmaceutical, biotech, and medical device fields. The employees who will benefit include:
  • QA and QC managers
  • Disinfectant validation managers
  • Operations managers
  • Clean room managers
  • Personnel and contractors that clean and disinfect clean rooms
  • EH&S managers
  • Regulatory compliance managers and environmental monitoring managers
Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has consulted numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Novartis, and Baxter.

Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

Available Options

Recording: Access the training Recording for 6 months from any location

$279

CD: Shipped within 2 working days

$389

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$2,249

10 Member group: 10 can Attend Live Meeting Online from any location globally

$3,689
For discounts and offers call support

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