2020 ISPE Aseptic Conference

Evolution in Aseptic Processing: Flexible and Reliable Solutions

Meet newly confirmed keynote for the 2020 ISPE Aseptic Conference, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA.

Keynote speaker for the 2020 ISPE Aseptic Conference, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA

His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with the FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, he is leading ORA’s pharmaceutical collaboration efforts under the Program Alignment initiative.

Alonza Cruse will provide current regulatory perspectives on aseptic processing during his keynote presentation, and answers your most pressing quality and regulatory questions directly with six FDA colleagues during the Interactive Regulatory Panel.


While many conferences just discuss the theoretical aspects of aseptic, barrier, and containment, the 2020 ISPE Aseptic Conference provides you with insights from aseptic professionals with 30+ years of experience, representing global companies that have implemented projects and technologies of peak interest.

Don't miss your chance to be immersed in collaborative, thought-provoking sessions featuring:

  • Face-to-face interaction with the FDA
  • Hot topic discussions
  • Owner experiences and lessons learned
  • Case study presentations
  • Group breakout discussions

Sneak Peek of What to Expect

How will the new EC GMP Guide Annex 1 impact the future of aseptic processing? What are some of the latest developments in barrier/isolator technology?

Jörg Zimmermann, 2020 ISPE Aseptic Conference Chair, Vice President Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co KG, answers these questions and more!


Conference Highlights


Featured Sessions


TOPICS

  • Automated Visual Inspections
  • Advanced Therapy Medicinal Products (ATMPs)
  • Alternate Decontamination Technologies
  • Aseptic Processing Science & Technology
  • Cell Therapy Scale-Out Planning
  • Cytotoxics, Robotics, High Potent Products
  • Facility Design & Expansion Case Studies
  • Formulation-Filling for Viral Vectors
  • High-Speed Syringe Filling Expansion
  • Modernization of a Legacy CDMO 
  • Robotic Applications in Aseptic Processing
  • Small-Scale/Clinical Manufacturing
  • Standardization of Extractables Testing
  • Sterile Connectors & Materials Transfer

ISPE's work was the single most important thing in the evolution from the old legacy Aseptic processing operations to isolator technology and other barrier technologies.

Richard Friedman

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
Pharmaceutical Market Director
CRB
Klaus Ullherr
Senior Product Manager
Syntegon Technology
Matthew P. VonEsch
AVP, Xeno and Regenerative Medicine Operations
United Therapeutics Corp.
Keith W. Weseli, CPIP
Director of Operations, Midwest Region
CAI