Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing

Why Should You Attend:

Training on personnel practices and microbial control on process equipment are a critical part of your facility operations and overall control program to meet FDA, EMA, IMB, and MHRA regulations. This process involves personnel training and having a sound cleaning and disinfection program to control microbes on process equipment surfaces in the cleanroom operation.

This 90-minute presentation will cover all the necessary components that will allow end users to be in compliance with FDA, MHRA, IMB, and EMA.

Areas Covered in the Seminar:

• Conducting audits of personnel practices.
• Using proper gowning and apparel.
• Addressing bioburden and cleaning and sanitization or process equipment.
• Discussing the most current methods for applying disinfectants, sanitizers, and sporicides on process equipment and in the cleanroom.
• The need to control bioburden involves a sound cleaning and disinfection program.
• Effective methods for controlling residues.
• All the necessary components will be discussed that will allow end users to be in compliance with FDA and EMEA.

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
• Regulatory Managers
• Lean Managers
• Personnel and contractors that clean and disinfect cleanrooms
• EH&S Managers
• Regulatory Compliance Managers & Environmental Monitoring Managers

Instructor Profile:

Mr. Polarine, is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over twelve 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 a co-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, SWE, and Barnett International on cleaning and disinfection and contamination control. He serves on the PDA’s Environmental Monitoring and Biotech Interest Groups and on the PDA Cleaning and Disinfection Task Force. He is also Active with the IEST Special Topics Committee on Cleaning and Disinfection. Mr. Polarine also frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online 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, 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.

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