This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program.
Areas Covered in the seminar:
- 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:
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
- Regulatory Compliance Managers & Environmental Monitoring Managers
Instructor Profile:
Jim Polarine, is a technical service specialist at STERIS Corporation. He has been with STERIS Corporation for over eight 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 disinfection and sanitation in cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several book 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 has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International on cleaning and disinfection and contamination control.
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 safety.
