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ISPE

FDA Compliance

ISPE to Present Conference Focused on GAMP Principles

Three educational tracks will be dedicated to manufacturing, laboratory, and IT best practices

Published: Friday, August 19, 2011 - 12:15

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association serving more than 22,000 pharmaceutical science and manufacturing professionals, will present a conference focused on good automated manufacturing practices (GAMP). The event, “Improve Productivity with Risk-Based Systems Validation,” will take place in New Brunswick, New Jersey, on Sept. 12–13, 2011, and will be offered again in Brussels, Belgium, on Nov. 14–15, 2011.

“ISPE has been issuing GAMP resources since the inception of GAMP, and therefore has a responsibility to the industry to focus on real-world solutions for real-world challenges,” says ISPE president and CEO Bob Best. “2011 marks the 20th anniversary of GAMP, so it seemed like the perfect time to bring together some of the top GAMP experts in the world for an intensive look at GAMP concepts. The leaders of our three most-active communities of practice—GAMP, project management, and commissioning and qualification—have worked hard to develop a set of sessions that fulfill ISPE’s responsibility and address several of the industry’s most vital needs.”

Improve Productivity with Risk-Based Systems Validation will feature three educational tracks that address the topic of systems validation as viewed through the lens of manufacturing, laboratory, and information technology infrastructure concerns. These three tracks will be book-ended by an opening plenary session on validation productivity led by renowned GAMP expert, David Selby, and a closing plenary session on data integrity led by FDA compliance officer George Smith, and internationally-recognized computer systems expert, Sion Wyn. Sessions will include opportunities to interact with regulators in workshops and case studies.

Track 1: Manufacturing will discuss the challenges of automation projects, and will feature instructor-led workshops designed to help participants understand how to deliver compliant, cost-effective automation projects to market faster.

Track 2: Laboratory examines the concept of validation within the laboratory environment and features regulatory representatives along with GAMP subject-matter experts to help attendees gain a better understanding of what regulatory authorities are looking for in relation to quality systems with the help of GAMP 5.

Track 3: Information technology will help participants understand the regulatory impact of new technologies by bringing regulators and industry experts together for a roundtable discussion of virtualization, cloud computing, and outsourcing.

In keeping with the event’s theme of celebrating and advancing GAMP concepts, ISPE is offering all members who attend either GAMP event, whether in New Jersey or Belgium, a 20-percent discount on all GAMP guidance documents, including GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems and the recently released GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition). A 20-percent discount will also be extended to purchases of commissioning and qualification guidance documents, including the new ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.

The New Jersey GAMP conference will be presented in tandem with the ISPE New Jersey Chapter Technology Showcase. The technology showcase features exhibits of the latest products and services from top industry suppliers, as well as a special keynote presentation by Richard Bagger, chief of staff to New Jersey Gov. Chris Christie. Bagger has a strong background in the pharmaceutical industry, having most recently served as senior vice president of public affairs for Pfizer’s worldwide biopharmaceutical businesses. The event will also offer complimentary food and drinks for preregistrants and all attendees of the GAMP conference.

For more information and to register for the conference, visit www.ISPE.org/2011RiskBasedSystemsLanding, or call ISPE Member Services at (813) 960-2105. For press passes to attend this event, contact Danielle Hould, ISPE communications manager, by telephone at (813) 960-2105 or via e-mail at dhould@ispe.org.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.