A Future of MQL and Managing Risk Release



12th September 2024 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | John R. Logar, Senior Director, Sterility Assurance at Johnson & Johnson |BOOK FREE SEAT FOR THIS WEBINAR

The concept of a Microbiological Quality Level (MQL) has been proposed as a method for determining the acceptable level of microbial contamination permitted during the manufacturing of or on a finished pharmaceutical, biopharmaceutical or combination product. The Kilmer RMM and PAT collaboration teams, along with ASTM Committee E55, have been exploring the use of Microbiology Quality Level (MQL) as means to enabling this future and this webinar will introduce and explore this concept as a means of determining probability/quantification of microbial risk for each step and its contribution to the final product as a mechanism to differentiate the microbiological quality of finished product.

John R. Logar, Senior Director, Sterility Assurance at Johnson & Johnson

John Logar is the Senior Director, Sterility Assurance at J&J Microbiological Quality and Sterility Assurance (MQSA) and is responsible for leading technical subject matter experts (SP6) in support of aseptic processing and sterilization activities across Johnson & Johnson and is responsible for the sterilization operations at the R&D center in Raritan, NJ.  John serves as a member of the J&J MQSA Leadership Team and is a co-lead for the Kilmer Collaboration Teams.  In addition, he helped to bring back the J&J Kilmer Conference and served as the conference program chair in 2016, 2019 and 2022.

John has over 25 years of experience in sterility assurance of healthcare products and is an industry recognized expert in radiation sterilization as well as a strategic leader in the development and implementation of consensus standards and training programs.  He served on the ASTM International Board of Directors for 9 years and served as the Chair of the Board in 2021.  Currently, he is the chair of ASTM committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and serves on the executive committee of ASTM Committee E61 on Radiation Processing: Dosimetry and Applications.  In addition, John serves as the Convener of ISO/TC85 WG3 on Radiation Dosimetry.


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