FDA Official to Speak at ISPE Aseptic Processing Event
ISPE, the International Society for Pharmaceutical Engineering, reports that Rick Friedman, Associate Director, OMPQ, US FDA, will be the plenary speaker at the association’s two-day event on aseptic processes for the pharmaceutical industry. The event will take place on 4 – 5 March 2013 in Baltimore, Maryland USA.
“ISPE conferences are an important neutral meeting-ground for regulators and pharmaceutical professionals from around the world to discuss technical challenges,” said Nancy Berg, ISPE President and CEO, in a press release. “By bringing together top industry experts and high-level regulators like Mr. Friedman, ISPE will facilitate collaboration and sharing of best practices that is essential to the production of a safe global drug supply.”
Discussions will focus on disposables, barrier isolation and containment technologies, cleaning, and sterilization. Regulators and pharma experts will present state-of-the-art developments in sterile process improvements, risk mitigation, cost-effective processing, and innovative applications.
Other event speakers include:
- Charlotte Enghave Fruergaard, PhD, Director of Technology, NNE Pharmaplan, 2012-2013 Chair, ISPE International Board of Directors, Aseptic Conference Honorary Chair.
- Destry Sillivan, Senior Regulatory Review Officer, US FDA.
- Robert Sausville, Director, Division of Case Management (DCM) Office of Compliance and Biologics Quality, at FDA’s Center for Biologics Evaluation and Research, US FDA.
- Dave Doleski, Acting Director, Division of Good Manufacturing Practice Assessment, OMPQ, OC, CDER, US FDA.
Pharma industry executives serving as moderators include:
- Ryan Hawkins, Vice President Operations, Cook Pharmica, USA.
- Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA.
- Joerg Zimmermann, Director Process Development and Implementation, Vetter Pharma Fertigung GmbH & Co. KG, Germany.
- Rebecca Brewer, Director, Validation and GMP Compliance, Dober Group, USA.
- Gordon Leichter, PhD, Regional Sales Manager, Belimed Inc., USA.
More information on the 2013 ISPE Aseptic Intensive, including complete education details and registration information, is available at www.ISPE.org/2013AsepticConference.