ISPE Announces Leaders from FDA, PIC/S, and Johnson & Johnson as Keynote Speakers for Global Aseptic Event
24 February, 2022
ISPE announced three keynote presenters for the 2022 ISPE Aseptic Conference, taking place 14–15 March 2022 in North Bethesda, Maryland and virtually. Now in its 31st year, this signature event has established itself as the pharmaceutical industry's leading source on advancing aseptic and barrier operations and providing invaluable opportunities for peer-to-peer learning through interactions with industry and regulatory leaders.
This year's event features a dynamic line-up of thought-provoking keynote presentations led by prominent leaders in the pharmaceutical industry.
Confirmed Keynote Presenters:
ORA Update – Navigating our Oversight through COVID-19 and Beyond
Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under the Program Alignment initiative.
Harmonization Efforts of PIC/S and the Impact on Aseptic Processing
Paul Gustafson is currently the PIC/S Chair and has been a member of the PIC/S Executive Bureau as Chairperson of the PIC/S Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP) since 1 January 2014. The PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. Paul is also a Senior Corporate Regulatory Compliance and Enforcement Advisor within the Regulatory Operations and Enforcement Branch of Health Canada.
Microbiological Quality and Cultivating Emerging Leaders
With over 38 years’ experience in sterility assurance, Joyce Hansen joined Johnson & Johnson as Vice President of Sterility Assurance in 2012. Joyce is responsible for providing strategic vision, leadership and governance for sterility assurance E2E lifecycle management for sterile products (aseptically produced or terminally sterilized), and the microbial control for non-sterile products. Additionally, Joyce is responsible for Johnson & Johnson’s representation in U.S. and international sterile and aseptic standards settings and internal sterile process knowledge management activities including learning, standards, competencies, and best practices to Johnson & Johnson companies worldwide. She is a member of the Johnson & Johnson Quality & Compliance Leadership Team.