Gaining and Re-establishing Control of your Clean Room

  • Speaker:Joy McElroy
  • Duration:90Min
  • Product Code:GRC-90320

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries 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.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • 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 - How it works

  • Free shipment 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 contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

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: 6 Months Access to the Training which can be accessed from any location

$269

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

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

$2,659

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$3,639

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