Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company



10th April 2025 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Luyen Nguyen Global Sterility Assurance and Microbiology Lead at Takeda, Hilary Chan Global Sterility Assurance and Microbiology Lead at Takeda |BOOK FREE SEAT FOR THIS WEBINAR

Establishing a personnel monitoring (PM) program requires a risk-based approach per the current EU Annex I. Presently, there is no specific industry or regulatory guidance on how to establish sample locations and sampling frequencies using Quality Risk Management (QRM) for personnel monitoring and the methodology behind a risk-based approach can vary greatly from site to site. Implementing a global risk-based methodology is desirable for consistency.  Takeda has developed a global personnel monitoring risk assessment tool that can be used across a range of production facilities.  This tool applies to both gowning qualification sample site determination and routine personnel monitoring associated with batch production.  Utilizing QRM principles, contamination hazards and sources were identified and assessed to inform risk scoring criteria.  The personnel monitoring assessment takes into consideration the process understanding of both gowning and manufacturing operations. A case study for the application of the risk-based tool will be presented.

Presented by Luyen Nguyen Global Sterility Assurance – Microbiology Lead at Takeda

Luyen Nguyen is a Global Sterility Assurance and Microbiology Lead at Takeda and is based out of Champlin, MN. Luyen has experience in the pharmaceutical industry, supported both parenteral and low bioburden manufacturing facilities from a contamination control perspective. In her current role, Luyen provides technical expertise to resolve microbial contamination issues, drive continuous improvement initiatives, and ensure alignment with industry and regulatory requirements within the global network. Luyen holds a Bachelor’s degree in Biochemistry from University of Saint Thomas.

and also presented by Hilary Chan Global Sterility Assurance and Microbiology Lead at Takeda

Hilary Chan is a Global Sterility Assurance and Microbiology Lead at Takeda where she is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations.  She is a global business process owner and community of practice network lead for microbiology and contamination control related topics.  She is an invited speaker at industry conferences, has authored various scientific publications, and is active in industry collaborations. Hilary has 24 years of experience in the industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.


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