(TAMPA, FLORIDA, USA, 18 August 2011) – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced today that it will present a conference focused on Good Automated Manufacturing Practices (GAMP®). The event will take place in New Brunswick, New Jersey, USA on 12-13 September 2011, and will be offered again in Brussels, Belgium on 14-15 November 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. 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,” said ISPE President and CEO Bob Best. “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.”
Themed “Improve Productivity with Risk-Based Systems Validation,” the event 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.
The Manufacturing track 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. The Laboratory track 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 GAMP5. The Information Technology track will help participants understand the regulatory impact of hot new technologies by bringing regulators and industry experts together for a round table 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 a 20% discount on all GAMP Guidance Documents, includingGAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems and the recently releasedGAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition). A 20% 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, New Jersey Governor Chris Christie’s Chief of Staff. Bagger has a strong background in the pharmaceutical industry, having most recently served as Senior Vice President, Public Affairs for Pfizer’s Worldwide Biopharmaceutical Businesses. The event will also offer complimentary food and drinks for pre-registrants and all attendees of the GAMP conference.