Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
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.
Course Objective:
• 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 cleanroom after a worst case event.
• Excursion events will be discussed and case studies will be covered regarding excursion events.
Course 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 cleanroom operation
• Critical Steps need to release the cleanroom for manufacturing
• Routine cleaning and disinfection strategies
• Utilities
• Contamination
• Environmental monitoring
• Establishing control of the cleanroom after a worst case event
• Excursion events
• Case studies regarding excursion events
• Excursion investigations and troubleshooting parameters
What You Get:
• Training Materials
• Live Q&A Session With our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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
• Cleanroom managers
• Personnel and contractors that clean and disinfect cleanrooms
• EH&S managers
• Regulatory compliance managers and environmental monitoring managers