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10:45am - 12:00pm EDT - March 15, 2022
Mr. Keith W. Weseli, CPIP, Commissioning and Qualification Project Director, Stevanato Group; Andrew Spasoff, Head of Development Quality Biologics, AstraZeneca; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US; Brian K. Smith, Director, Project Management, SKAN US, Inc.

Projects during the Pandemic—Technical and Process Case Studies | Come and learn how pharmaceutical companies have responded to the recent operational impediments. Two case studies will be highlighting the challenges of project execution last year, and how their firms overcame them. One study will examine the Process Performance Qualification of COVID-19 vaccine production and the other will delve into upgrading aseptic filling facilities while minimizing the impact to production.


Tuesday
10:45am - 10:50am EDT - March 15, 2022
Mr. Keith W. Weseli, CPIP, Commissioning and Qualification Project Director, Stevanato Group

Tuesday
10:50am - 11:10am EDT - March 15, 2022
Andrew Spasoff, Head of Development Quality Biologics, AstraZeneca

Normally, any lot manufactured prior to the start PPQ, could not be used for commercial distribution. Since the COVID-19 pandemic was not normal, we developed a novel approach to overcome the challenges of short development and tech transfer timelines to speed safe and efficacious vaccine doses to patients. The presentation will discuss compliance, GMP and regulatory considerations that were fundamental to the success of this approach. As a result of this presentation participants will better understand some of the vaccine commercialization challenges AZ faced, specifics about what regulators around the globe thought of this idea and the ideas on how this agile CMC approach could have broader applicability.


Tuesday
11:10am - 11:30am EDT - March 15, 2022
Brian K. Smith, Director, Project Management, SKAN US, Inc.; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US

A SKAN case study reflects how an active facility can upgrade existing aseptic cartridge filling lines with minimal impact to production schedules. SKAN developed innovative solutions by combining their regulatory expertise, process, equipment knowledge and creativity to design compliant upgrades for the future, and to ensure higher sterility assurance levels. SKAN engineered and installed (3) RABS Retro-fits to the existing customer productions line. Each line was a different layout with different features that required different solutions. Their combined experience in aseptic manufacturing, current and new Aseptic Guidelines allowed them to design unique features on each line. The key to successful retro-fits like this is the understanding of how the equipment functions, how the equipment can be altered/improved, how the existing aseptic process works and what can be improved. During the design phase, the teams took great care of, and are in understanding of the ergonomics and the airflow within the room and Barrier/RABS. This was all accomplished with minimal down time.


Tuesday
11:30am - 12:00pm EDT - March 15, 2022
Mr. Keith W. Weseli, CPIP, Commissioning and Qualification Project Director, Stevanato Group

03:30pm - 05:00pm EDT - March 15, 2022
Mr. Michael G. Higgins, Sr. Director External Engagement and Supplier Quality, Moderna Therapeutics; Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA; Paul A. Gustafson, 2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada; Mr. Rick Friedman, Deputy Director, Office of Manufacturing Quality, FDA/CDER; Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER; Robert Sausville, Director, Division of Case Management, FDA/CBER/OMPT/OCBQ; Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs; Thomas J. Arista, Consumer Safety Officer, FDA/ORA

Interactive Regulatory Panel | This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees. together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.


Tuesday
03:30pm - 04:50pm EDT - March 15, 2022
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA; Paul A. Gustafson, 2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada; Mr. Rick Friedman, Deputy Director, Office of Manufacturing Quality, FDA/CDER; Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER; Robert Sausville, Director, Division of Case Management, FDA/CBER/OMPT/OCBQ

Interactive Regulatory Panel | This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees. together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.


Tuesday
04:50pm - 05:00pm EDT - March 15, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs