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PDA New England Chapter Webinar: A Risk Based Cleaning and Disinfection Program

Jul 15, 2020
2:00 PM
-
3:30 PM
| Eastern Standard Time
Online
  • Chapter
  • Online
Register Now

Overview

In this webinar offering, we will discuss designing a risk-based cleaning and disinfection program. Recent developments in monitoring, contact tracing and social distancing. Current industry trends, global regulatory expectations and essential elements needed to keep the cleanroom in a state of control. Current regulations, disinfectant and sterilant technologies, operator safety and applications of these products including videos. Current industry trends in disinfectant rotation, sterility, application techniques, and rinsing. Regulatory expectations of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, and ANSM inspectors. Annex 1 draft; PDA TR No. 70: “Fundamentals of Cleaning and Disinfection…..Aseptic Manufacturing Facilities”; USP 43 Chapter 1072: “Cleaning and Disinfection.” FDA Warning Letters and FDA 483s.

Highlighted Speakers

Jim N. Polarine
Jim N. Polarine
STERIS Corporation
Bio
Jim N. Polarine
STERIS Corporation

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 and microbial control 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 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’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley and Technical Coordinator for the IEST. 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.

Who Should Attend

  • Quality Control Microbiology Managers
  • Quality Assurance Managers
  • Cleanroom Managers
  • Operations Managers
  • Production Managers
  • Validation Managers
  • Regulatory Affairs Managers

Registration Fees

Register Now
Registration Type Price
Member* $25.00
Non-Member $65.00

*A special discount is available for PDA Members. To get this discount code, send an email to PDA Membership Dept: [email protected] or Shanna Morgan, [email protected].

NOTE: When entering a discount code, ensure that all characters are in UPPER case, when applying. Do not cut & paste.

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