Establishing and Regaining Control of Cleanroom

3,000.007,000.00

Product Id : FDB2757
Presenter : Joy McElroy
Scheduled On : May 18, 2019 at 10:30 PM (India Time)
Duration : 90 Minutes
Clear

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.

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.

Areas Covered in the Session :

  • 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

Who Should Attend:

  • 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
Purchase Options

1. Live Session, 2. Recording Access, 3. Live & Recording Combo

Presenter Details

Joy McElroy
Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.