(TAMPA, FLORIDA, USA, 09 APRIL 2009) – ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, announced today that it will present several operational efficiency sessions—highlighted by an interactive workshop on commissioning and qualification—at its Chicago Training being held on 11-14 May 2009 at the Hyatt Rosemount in Chicago, Illinois, USA.
ISPE’s Chicago Training will put real-world, cost-effective solutions in the hands of industry professionals while providing the hands-on experience required to improve operational efficiency at their facilities.
One of the highlights of the event will include a multi-media workshop entitled, Application of Commissioning and Qualification, Applying the Commissioning and Qualification Baseline® Guide Principles addressing the application of the principles in the Commissioning and Qualification Baseline® Guide for a project consisting of process equipment components, classified area, critical utilities, and an associated automation platform. The classroom and interactive webinar activities include the formation of a project team; development of critical requirements for projects based on current good manufacturing practices (cGMPs) and the basis of design; performance of an impact assessment including system impact and component criticality assessments; and performance of enhanced design review.
The fundamental course, “Basic Principles of Computerized Systems Compliance, Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems,” held on 11-12 May, will provide the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities. Participants will receive a complimentary copy of GAMP 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems.
Developed for pharmaceutical manufacturing and biotechnology professionals to help increase knowledge in their respective fields, the training will also focus on current issues, including technology transfer for finished dosage forms, pharmaceutical water generation, HVAC for pharmaceutical facilities, pharmaceutical water operation, Q7A essential knowledge, and process validation for biotechnology manufacturing.
Recognized industry experts — including Norman Goldschmidt, principal and founder of Pharma Engineering Advisors, and former senior director of engineering strategy/design in global engineering at Bristol-Myers Squibb — will present relevant curriculum that will give professionals the tools they need to be successful in their careers while earning Continuing Education credits. In addition, a number of Chicago classroom training courses contain knowledge related to the seven technical knowledge competency areas for the Certified Pharmaceutical Industry Professional™ (CPIP™) certification program.
In addition, ISPE’s Midwest Chapter will be hosting a tabletop vendor exhibition, as well as a poster competition that will conclude at ISPE’s 2009 Annual Meeting in San Diego, California, USA on 8-11 November 2009.
For more information or to register for ISPE’s Chicago Training, visit www.ISPE.org/chicagotraining.
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.
