ISPE's 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology Download the Event Brochure Now! ( 940 KB)
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
Enghave Fruergaard, Ph.D.
Past Chair, ISPE International Board of Directors
Investigator/National Expert, Biotech, FDA/ORA/ORO/DDFI
Associate Director, FDA/Office of Manufacturing and Product Quality/CDER
Richard L. Friedman is responsible for oversight of CGMP and drug quality programs to assure scientific and risk-based decisions. This position includes review of major regulatory action recommendations regarding inspections and manufacturing site acceptability; promoting sound risk management of major defects (e.g., potential recalls); program prioritization; and analyzing emerging drug quality trends. Mr. Friedman is also the co-chair of FDA’s Pharmaceutical Quality Systems Workgroup, the Standards Working Group, and the CDER/ORA Strategic Science and Compliance Committee.
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!
- Rick Friedman, Associate Director, FDA/Office of Manufacturing and Product Quality/CDER
- Bob Sausville, Director, FDA/Division of Case Management/CBER/OMPT/OCBQ
- Dave Doleski, Director, FDA/Division of DGMPA/CDER
- Tara Gooen, Branch Chief (acting), FDA/Division of DGMPA/CDER
- Destry Sillivan, Senior Regulatory Review Officer, FDA/CBER/OMPT
- Thomas Arista, Investigator/National Expert, Biotech, FDA/ORA/ORO/DDFI
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