A Future of Microbiological Quality Levels and Managing Risk Release

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.

Followed by Sebastian Scheler, Co-Founder, Managing Director, Chief Methodologist, Frame-by-Frame Risk Profiling Supervisor at Innerspace

Sebastian is a passionate about pushing the boundaries of advanced risk assessment technologies to unlock new possibilities for designing and managing manufacturing processes in pharma. He spearheads a dynamic team of life science professionals and software developers. The core focus of his professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, Sebastian has always been captivated by the intersection of human behavior and technology. His passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behaviour measurement systems.

Sponsored by Innerspace

Innerspace GmbH: As specialists for immersive training solutions with VR technology, Innerspace GmbH combines four areas of expertise: (1) Risk-based, effective, measurable, scalable training, (2) state-of-the-art Virtual Reality technology, and industry understanding with a (3) special focus on a novel technology for risk assessment and risk management, called “Frame-by-Frame Risk Profiling”. Innerspace sees itself as an end-to-end solution provider that maps and professionally accompanies all elements of QRM, process design and training.