2014 ISPE Aseptic Conference

Aseptic Processing Technologies and Disposables

Track Leaders:

 PhotoJörg Zimmermann
Director, Process Development and Implementation,
Vetter Pharma-Fertigung GmbH & Co. KG, Germany

 PhotoKlaus Ullherr
Product Manager, Robert Bosch GmbH, Germany

Are disposables living up to their reputation for transforming the industry? Delegates will answer this and other questions as they examine the advances in aseptic processing. Presentations and discussions on disposables in particular will address various stages in the production chain. A broad range of topics important to aseptic processing, from compounding to fill-finish and lyophilisation will be addressed allowing for comprehensive discussion and problem solving.

Aseptic Processing Technologies and Disposables Track Participants will:

  • Interact directly with multiple regulatory participants for clarification of current guidance and expectations
  • Take away up-to-date information on testing methods, process controls and filtration
  • Learn from case studies on equipment replacement projects, disposables manufacturing and the challenges of filling live vaccines
  • Explore innovative uses for disposables and their applicability in varying environments
  • Be prepared to manage and protect employees during the production of cytotoxic products

View the Track Agenda ( 158 KB)

 

Welcome and Introduction

Charlotte Enghave Fruergaard, Ph.D., Partner, Global Consulting, NNE Pharmaplan, Denmark

Keynote Presentations

Thomas Arista, Investigator/National Expert, Biotech, FDA/ORA/ORO/DDFI, USA

Rick Friedman, Associate Director, Office of Manufacturing and Product Quality, FDA/CDER, USA

View Other Tracks:

Barrier Isolation – RABS Track

Regulatory Panel

 

Announcements:

Handouts are now available!