In this webinar you will learn:
I. How to ensure your disinfectant validation program is a success
• Learn disinfectant testing methodologies.
• Review “real world” examples of disinfectant efficacy tests.
• Increase awareness of pitfalls encountered during testing.
II. Troubleshooting problems related to disinfectant efficacy testing.
• Problems associated with porosity of substrates
• Neutralizers that are toxic to cells
• Recovery steps that give problematic results
• Discover the steps for success
III. Ensuring a Complete Validation Program
• Hard surface testing vs. suspension testing
• EM data trending
• In Situ Testing
• Meeting FDA, EMEA, and Japanese Commission
IV. Case Study
• Real world example of how disinfectants are validated
• How data from the laboratory is correlated to the real world
• Common issues that can be related to real world cleanrooms
V. Regulatory guidelines related to disinfectant validation
• USP 31 NF-26 General Chapter <1072>
• New Aseptic Processing guidelines (2004)
• ISO guidance documents (ISO 14698 parts 1-3)
• Other current guidance documents and trends
• Additional efficacy testing methods: CEN testing, AFNOR, DGHM, ASTM, AOAC, and TGA
Instructor: Jim Polarine
Mr. Polarine is Manager of Technical Services at STERIS Corporation. He has been with STERIS Corporation for over nine years, where his current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several books and article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is an author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He is part of the faculty at the University of Tennessee Parenteral Medication course. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, on cleaning and disinfection and contamination control. Mr. Polarine also frequently presents global industry webinars on Cleaning and Disinfection. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, ISPE, IEST, ASM, AALAS, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veteran’s Affairs 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
FEE: $385 for one person.
$700 for 2-5 people
$999 for 6-10 people