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.
Why Should You Attend:
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.
- 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 cleanroom after a worst case event.
- Excursion events will be discussed and case studies will be covered regarding excursion events.
Senior Technical Service Manager ,
Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.
This 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 & Environmental Monitoring Managers