Aseptic Drug Processing, Barrier Isolation Covered at Upcoming ISPE Conference
ISPE’s 23rd Annual Conference on Barrier Isolation, RABS, and Aseptic Processing Technology will feature keynote speakers from FDA. Speaking will be Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, and Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ. The conference will be held in Washington, DC, February 24 – 25.
Arista and Friedman will join honorary chair Charlotte Enghave Fruergaard, PhD, Partner, Global Consulting, NNE Pharmaplan to begin the two-day conference highlighting significant issues related to barrier isolation – RABS and aseptic processing technologies and disposables.
“Preventing contamination of injectable drugs is critical to patient safety. ISPE is dedicated to advancing industry and regulatory understanding and collaboration on issues related to aseptic drug manufacturing processes through our signature Aseptic Processing Conference,” said ISPE President and CEO Nancy Berg in a statement. “This year’s event builds on the conversations from previous conferences to encompass the most up-to-date industry thinking on technology solutions, best practices and lessons learned in real-world case studies.”
Other speakers include aseptic processing experts from FDA, Merck, Merck Vaccines, Genentech, Novartis, BiogenIdec, AstraZeneca, Boehringer-Ingelheim, and Eiasi, among others.
The presentations, discussions, and case studies will be divided into two conference tracks:
Aseptic Processing Technologies and Disposables, led by Jörg Zimmermann, Director, Process Development and Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany, and Klaus Ullherr, Product Manager, Robert Bosch GmbH, Germany
Barrier Isolation and RABS, led by Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA and Ryan Hawkins, Vice President of Operations & COO, Cook Pharmica, USA
For more information please visit www.ISPE.org/2014AsepticConference.