Location: Dublin, IrelandThere are limited spaces available at this exclusive 2-day hands-on course at the National Institute for Bioprocessing Research & Training (NIBRT). The training course will cover best practices, regulatory expectations and the current challenges in contamination control, environmental monitoring, and disinfectant qualification.
Who Should Attend: Biopharmaceutical and medical device manufacturer personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.
-Identify critical attributes of cleanroom design and operation, and recognize issues that impact controlled environments
-Identify and apply the regulations surrounding cleaning and disinfection of critical environments
-Assess the cleaning and monitoring requirements for start-up and qualification of cleanroom safter construction, maintenance, malfunction or contamination
-Draft compliance procedures for cleaning programs that are practical for employees, including all essential elements, addressing training of staff, and avoiding common mistakes
-Develop and optimize an EM program that is risk and science based, fully aligned with regulatory expectations
-Recognize and explain the pertinent regulations and features of disinfectant efficacy testing (DET) involving coupon and suspension testing relating to EN- 13697 (2015) and ASTM E2197-17
-Identify and overcome common errors in DET
Presenters (Biographies below):
-Beth Kroeger, STERIS Technical Services Manager
-Aaron Mertens, STERIS Technical Services Manager
-Jim Polarine, STERIS Senior Technical Services Manager
-Joseph McCall, STERIS Technical Service Specialist
Date: September 25-26
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Beth Kroeger is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE) and the National Institute for Bioprocessing Research (NiBRT). Beth has over 25 year’s industry experience in Biopharmaceutical and Oral Solid Dose manufacturing operations.
Aaron Mertens has been a member of the STERIS Life Sciences Contamination Control Solutions as a Technical Service Manager since January 2015. In this role, Aaron has responsibility for providing global technical support primarily for Critical Environments (i.e. environmental sanitizers, disinfectants, sporicides), Sterility Assurance Products (i.e. biological and chemical indicators), and Barrier Products Solutions (i.e. sterilization wrapping), application and validation.
Jim Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and has published several PDA book chapters and articles related to cleaning and disinfection and contamination control.
Joe McCall is a Technical Service Specialist with STERIS Life Sciences. He specializes in microbial control, environmental monitoring, contamination investigations and cleanroom issues. Joe has over 20 years of experience in the biopharmaceutical and medical device industries, specializing in aseptic processing, cleanroom qualification, environmental monitoring, and risk management. He provides global technical support and expert consultation services for Critical Environments.