ISPE Announces Leaders from FDA, PIC/S, and Johnson & Johnson as Keynote Speakers for Global Aseptic Event
The International Society for Pharmaceutical Engineering (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.
NORTH BETHESDA, Md., Feb. 23, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (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:
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations FDA/ORA
Presentation title: "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.
Paul Gustafson, 2022–2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada
Presentation title: "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.
Joyce Hansen, Vice President, Sterility Assurance, Johnson & Johnson
Presentation title: "Microbiological Quality and Cultivating Emerging Leaders"
With over 38 years of 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 microbial control for non-sterile products. Additionally, Joyce is responsible for Johnson & Johnson's representation in the 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.
To learn more about this event and to register, visit ISPE.org/Aseptic22.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000+ Members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
For more information, contact:
Amy Henry
Marketing and Communications Director
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1- 813-960-2105 Ext. 277
Email: [email protected]
ISPE.org
Media Contact
Amy Henry, ISPE, 1- 813-960-2105, [email protected]
SOURCE ISPE
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