(TAMPA, FLORIDA, USA, 11 MAY 2009) – ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, along with the China Centre for Pharmaceutical International Exchange (CCPIE), announced today that they will partner to bring a series of training courses specifically designed to meet needs of the Chinese pharmaceutical industry on 1-5 June in Shanghai and 8–12 June in Beijing.
Noted industry leader Gordon Farquharson, BSc (Hons), CEng, will be presenting the two ground-breaking training courses on sterile drug manufacturing facilities and pharmaceutical water systems at each of these events.
The Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide, FDA, EU/PICS and WHO Principles to Design and Operation course will review ISPE’s Sterile Manufacturing Facilities Baseline Guide, the US FDA’s 2004 Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, and the new March 2009 implementation of Annex 1 of the EU GMP. This course will help participants gain an understanding of the key requirements and GMPs for sterile products manufacturing facilities. Additional information will be reviewed from the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and from the World Health Organization (WHO).
During the Pharmaceutical Waster Systems: Regulation, Purification, Distribution and Validation course, participants will review the principles of design and operation of water systems used directly in pharmaceutical manufacturing, including the regulatory requirements, fundamental concepts, and principles for systems used to generate, store and distribute both compendial and non-compendial waters. These concepts include specification, design, installation, operation, testing, validation, and maintenance of components and systems.
For more information or to register for the ISPE-CCPIE Training Event, visit ISPE-CCPIE 2009 or contact the ISPE China office by tel: +86-21-5116-0265 or email: china@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.