Starting up a new cleanroom and releasing it for manufacturing involves a series of critical steps, and losing control after an excursion can halt production. This webinar on gaining and re-establishing control of your cleanroom covers both situations.
You'll walk through the steps to start a new cleanroom operation and the steps needed to release it for manufacturing, along with routine cleaning and disinfection strategies, current equipment and application methods, utilities, contamination and environmental monitoring.
Using a case study approach, the session then looks at excursion events and how to re-establish control of the cleanroom after a worst-case event.
WHY SHOULD YOU ATTEND?
FDA and EMEA regulated companies must validate their cleaning and disinfection programs and keep cleanrooms under control. This session helps pharmaceutical, biotech and medical device teams bring new cleanrooms online and respond well when things go wrong.
It suits QA and QC, operations, cleanroom, disinfectant validation, EH&S, regulatory compliance and environmental monitoring managers, and staff and contractors who clean and disinfect cleanrooms.
AREA COVERED
- Critical steps in starting a new cleanroom operation
- Critical steps to release the cleanroom for manufacturing
- Routine cleaning and disinfection strategies, equipment and application
- Utilities
- Contamination
- Environmental monitoring
- Excursion events, with case studies
- Establishing control of the cleanroom after a worst-case event
LEARNING OBJECTIVES
- Follow the critical steps to start up a new cleanroom
- Release a cleanroom for manufacturing
- Set routine cleaning and disinfection strategies and choose equipment and application methods
- Respond to excursion events using lessons from case studies
- Re-establish control of the cleanroom after a worst-case event
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
FDA and EMEA regulated companies must validate their cleaning and disinfection programs and keep cleanrooms under control. This session helps pharmaceutical, biotech and medical device teams bring new cleanrooms online and respond well when things go wrong.
It suits QA and QC, operations, cleanroom, disinfectant validation, EH&S, regulatory compliance and environmental monitoring managers, and staff and contractors who clean and disinfect cleanrooms.
- Critical steps in starting a new cleanroom operation
- Critical steps to release the cleanroom for manufacturing
- Routine cleaning and disinfection strategies, equipment and application
- Utilities
- Contamination
- Environmental monitoring
- Excursion events, with case studies
- Establishing control of the cleanroom after a worst-case event
- Follow the critical steps to start up a new cleanroom
- Release a cleanroom for manufacturing
- Set routine cleaning and disinfection strategies and choose equipment and application methods
- Respond to excursion events using lessons from case studies
- Re-establish control of the cleanroom after a worst-case event
- 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