Harmonized Manufacturing Network For Sterility Assurance


06th February 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company |BOOK FREE SEAT FOR THIS WEBINAR

This presentation will provide an understanding related to Global Guidance related to holistic Contamination Control Strategies.  The importance of cross-functional collaboration to ensure all aspects of the Contamination Control Strategies are properly applied and modified based upon appropriate feedback, including CAPA from deviations.  This presentation will also discuss how to identify and drive innovation within the manufacturing space to improve Sterility Assurance processes and development of future facility and process design.  Finally, this presentation will discuss how to manage regulatory interactions, which can lead to successful audits.

Presented by Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Batchelor of Arts (B.A.) in Biology.  After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001.  Mr. Ayers has held various roles within the Quality and Technical Services organizations.  In each position, Fred has helped advance Lilly’s state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert.  For Lilly’s Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site’s sterility assurance programs.  Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations.  He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations.  Fred has been a strong supporter and contributor to local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.


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