Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Jim Polarine
Designing an effective disinfectant validation program to meet FDA, MHRA, HPRA, EMA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, European Regulations, and Field Experiences as well as case studies will be conveyed that allow end users to determine that best methods to validate their products against their environmental isolates. Current industry best practices will be covered as well as potential pitfalls that can occur during testing.
Why should you attend: The topic of suspension and coupon studies will be discussed as well as possible errors that can happen with the testing. The FDA and other industry regulators have an expectation that disinfectants, sanitizers, and sporicides used in cleanrooms will need to be validated which has created an increased interest in coupon testing.
Areas Covered in the Session:
- Learn disinfectant testing methodologies.
- Review “real world” examples of disinfectant efficacy tests.
- Increase awareness of pitfalls encountered during testing.
- Troubleshooting problems related to disinfectant efficacy testing.
- Examples of disinfectant validation successes will be discussed.
Who Will Benefit:
- Quality Managers
- Regulatory Affairs
- 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
Jim Polarine is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over fourteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, 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 currently co-authoring articles. He is active on the PDA task force on cleaning and disinfection and the PDA task force on Microbial Deviations and a co-author on the technical reports. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group. He is a volunteer with the PDA Missouri Valley Chapter. He is part of the faculty at the University of Tennessee Parenteral Medication course. He is also active with the IEST Special Topics Committee on Cleaning and Disinfection. He has presented at key industry events for PDA, ISPE, GBPR, IPA, AALAS, IVT, University of Tennessee, SWE, Isomedix, and Barnett International on cleaning and disinfection and contamination control.
Mr. Polarine frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, Global Compliance Panel, and Executive Conferences. 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, ASTM, AAAS, AOAC, and ACS. 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.
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