ISPE's 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology Download the Event Brochure Now!
Preventing contamination of injectable drugs is critical to patient safety. Close scrutiny from the FDA and other global agencies keeps industry focused on effectively managing this risk. ISPE has long been recognized for high quality education events on the latest technology related to Aseptic Processing. This conference brings together both industry and regulatory representatives to highlight significant issues related to Barrier Isolation – RABS and Aseptic Processing Technologies and Disposables.
At the conclusion of this conference, participants will be able to:
- Understand and implement the latest technologies related to aseptic processing
- Clarify directly with regulators current GMP expectations to share with company leadership
- Apply lessons learned from user companies who can provide insights and benchmarks
- Impact company strategies and approaches to aseptic processing issues and challenges
Charlotte Enghave Fruergaard,
Past Chair, ISPE International Board of Directors
Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI FDA Perspectives on Aseptic Processing Technologies
Associate Director, Office of Manufacturing and Product Quality, FDA/CDER
Lifecycle Risk Management of Aseptic Processing Operations
The effective risk management of aseptic pharmaceutical processes and facilities begins with fundamental design decisions made at the manufacturing site and continues throughout the product lifecycle. Implementing dependable aseptic practices requires well-managed facilities processes, people, and early warning systems to assure process consistency and product safety. Hear current FDA perspectives on aseptic processing operations and recent examples of significant Inspection and Compliance issues at sterile facilities.
Regulators to provide current perspectives on Aseptic challenges and answer your questions during interactive panel discussion.
Questions and issues emerging from conference presentations and discussions will be presented for the regulatory panel to address during the concluding session. You won’t want to leave early from this conference!
- Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI
- Dave Doleski, Director, FDA/CDER/Division of DGMPA
- Rick Friedman, Associate Director, FDA/CDER/Office of Manufacturing and Product Quality
- Bob Sausville, Director, FDA/CBER/OMPT/OCBQ/Division of Case Management
- Destry Sillivan, Senior Regulatory Review Officer, FDA/CBER/OMPT
Thank You to Our Planning Team!
- Ryan Hawkins, Vice President of Operations & COO, Cook Pharmica, USA
- Gordon Leichter, PhD. Regional Sales Manager, Belimed, Inc., USA
- Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
- Klaus Ullherr, Product Manager, Bosch, Germany
- Jörg Zimmermann, Director, Process Development and Implementation, Vetter Pharma, Germany