2020 ISPE Aseptic Conference

Thank You for Making this Conference a Huge Success!

The 2020 ISPE Aseptic Conference delivered engaging presentations and case studies on cutting-edge topics with many opportunities to network and gain insights from top industry professionals. Check out the content below to get insights from the conference.

Highlights of the FDA’s Actions and Activities in Response to the Coronavirus (COVID-19)

Hear from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA, as he highlights some of the FDA’s actions and activities in response to the Coronavirus (COVID-19) at the 2020 #ISPE Aseptic Conference.

What Are Some of the Key Process Design Features That Are Needed for Autologous Cell Therapy?

Umit Verma, Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc., offers his expert insights during his presentation Planning for The Unknown – Autologous Cell Therapy Scale Out Planning at the 2020 #ISPE Aseptic Conference.

What Does the FDA Want?

Having had a long career history with the FDA, David Doleski, Compliance Head for Biologics Quality Operations, Sanofi, provided his insight into the mindset of a regulator during his keynote presentation How Perspectives Change: From Regulator to Regulated at the 2020 #ISPE Aseptic Conference.

Adapting to Standardization of Extractables Testing for Single-Use Components

Hear from Laura Moody, Product Manager, Primary Packaging, NA, Syntegon, as she answers a question that came about from her presentation Adapting to Standardization of Extractables Testing for Single-Use Components at the 2020 #ISPE Aseptic Conference.

What Are Some Hot-Button Issues for the FDA?

Having had a long career history with the FDA, David Doleski, Compliance Head for Biologics Quality Operations, Sanofi, provided his insight into the mindset of a regulator during his keynote presentation How Perspectives Change: From Regulator to Regulated at the 2020 #ISPE Aseptic Conference.

Testimonials

  • Regulatory presence at ispe event
  • Annual Meeting & Expo Highlights
  • Breen

Session Highlights

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  • Aseptic20 - Tim & Alonzo
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Conference Highlights

Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Chair/Board Ambassador
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Christa B. Myers
Aseptic and Sterile Products Market Director
CRB
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Matthew P. VonEsch
VP, Xeno and Regenerative Medicine Operations
United Therapeutics Corp.
Keith W. Weseli, CPIP
Commissioning and Qualification Project Director
Stevanato Group