Roadmap to Developing a Contamination Control Strategy in Pass-Thru Applications

This webinar will cover a risk-based approach to pass thru decon of critical items into cleanrooms, opened RABS, pass thru chambers, and BSC Hoods. There will be a focus on how to control hard to kill fungal spores such as Aspergillus and Chaetomium as well as bacterial spores and viruses (enveloped and non-enveloped). Recent case studies from the past few months in cell and gene therapy and compounding pharmacies will be discussed in relation to pass thru decon best practices. Published data will also be presented to convey effective methods in controlling bioburden into the APA. A focus on sanitizer, disinfectant, and sporicidal chemistries as well as other new technologies such as UV light will be discussed. This presentation well be a holistic approach to controlling bioburden from entering BSC Hoods and cleanroom operations.

Who should attend:

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Sustainability Managers

Instructor

Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection and Technical Report #88 on Microbial Deviations. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Vice President of Membership at IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MOand 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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Date

NEW DATE: September 7, 2023
10 - 11 a.m. Central Time

Online registration closes September 6. Registrations will still be taken after this rate if space permits.
 

Registration Information

Regular Rate
(through 9/6)
Member: $95
Non-member: $155

 

Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course for free! Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)

  • Transfers: All registrations are transferable to another person for the same event A $35 transfer fee applies. Transfer of a member registration to a nonmember registration will be charged the difference in fees.
  • Cancellations: Cancellation requests received 60 days or more prior to the start of the event will receive a full refund LESS a $75 administration fee. Cancellation requests received 30-59 days prior to the start of the event will receive a 50% refund. No refunds will be issued for cancellation requests received less than 30 days prior to the start of the event. IEST reserves the right to cancel course(s), in which case registrants will receive a refund of the fee. IEST is not responsible for any refund or remuneration for hotel, transportation, additional registration fees, tours, or other expenses related to attendance beyond the registration fee refund.
  • IEST reserves the right to cancel courses, in which case registrants will receive a full refund of the tuition fee.
  • Program and instructor(s) are subject to change.
  • .1 CEUs per class.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.