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 .