Gaining and Re-establishing Control of your Clean Room

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

$269

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Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
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Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

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

$269

CD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

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

$2,659

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

$3,639

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