(TAMPA, Fla. USA, 21 February 2013) – ISPE announced today that Rick Friedman, Associate Director, OMPQ, US FDA, will be the plenary speaker at the association’s two-day education intensive 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. “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.”
The two-day event will present the latest in aseptic processes. 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. In addition to Friedman, notable speakers at this conference 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 leading this event and 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.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org
