(TAMPA, FLORIDA, USA, 15 APRIL 2009) – ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, is bringing together a strong panel of industry leaders and U.S. Food and Drug Administration (US FDA) regulators to present the Global Supply Chain Integrity and Anti-counterfeiting seminar at the ISPE 2009 Washington Seminars and Courses – Engineering Regulatory Compliance, being held at the JW Marriott in Washington, DC, USA on 1-4 June 2009.
This ISPE seminar ? co-sponsored by IPEC-Americas ? is intended to help the pharmaceutical industry address recent concerns about the integrity of today’s complex pharmaceutical supply chain and to help companies assure a safe, efficacious drug supply, from the manufacturer to the final delivery to the patient.
Numerous regulators from the US FDA will present, including Ilisa Bernstein (Sr. Advisor Pharmacist, FDA’s Office of Policy) and Steven Silverman, Esq. (Assistant Director, Office of Compliance, CDER). A representative from the FDA’s Office of Policy and Program Planning in the Office of the Commissioner has also been invited to speak. Industry leaders will present valuable information related to supply chain integrity, including RX 360, a proposed model for industry cooperation in helping secure the supply chain. Seminar leaders include Brian Johnson (Director, Team Leader of COQA Americas, Pfizer Inc.), Zena Kaufman (DVP Quality Center, Abbott Laboratories), Janeen Skutnik (Director, Pfizer Inc.), and Thomas Zimmer, PhD (Senior Vice President Quality EHS, Boehringer Ingelheim GmbH).
Pharmaceutical professionals from logistics and distribution, purchasing, warehousing, manufacturing, quality assurance, regulatory affairs, research and development, senior experts, corporate security, regulators, suppliers, and patient organizations (pharmacists, physicians, and distributors) are encouraged to attend.
In addition, the ISPE 2009 Washington Seminars and Courses will cover topics such as Barrier Isolation; Product Quality Lifecycle Implementation (PQLI?); Packaging Challenges; C&Q and Validation Inclusive of Computer Systems Validation; Applied Risk Management; Facility Renovation; and GAMP? GPG on PCS Ver. 2 and Calibration Guide, Ver. 2.
The event will also include tabletop exhibits from more than 60 of the industry’s top suppliers of pharmaceutical manufacturing equipment, and networking opportunities for pharmaceutical industry professionals.
For complete seminar information, and to register, visit www.ISPE.org/washington, or call ISPE Members Services at tel: +1-813-960-2105. For press passes to attend this event, contact Marni Schribman, ISPE Communications Manager, by tel: +1-813-960-2105, fax: +1-813-264-2816, or email: mschribman@ispe.org.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
About IPEC-Americas
IPEC is a federation of four independent regional industry associations located in the United States, Europe, Japan and China. Over 300 national and multinational excipient makers, producers, and companies that use excipients in finished drug dosage forms are members of one or more of the four IPEC regional units. Visit www.ipecamericas.org for more information.
