News

July 20, 2017
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) . This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management) f...
July 17, 2017
ISPE announced its inaugural Asia Pacific GAMP® Data Integrity Conference, taking place 13 – 14 November at the NTU Alumni Club Auditorium in Singapore. Organized in partnership with the ISPE Singapore Affiliate, this uniquely focused event will take...
June 29, 2017
ISPE announced it will host its 2017 Annual Meeting & Expo in San Diego, California USA, from October 29 to November 1. At this signature event, attendees will explore how to navigate organizational and regulatory complexities to drive innovation and...
June 17, 2017
New ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities Is the Essential Toolbox to Aid in the Decommissioning Process ISPE announced the release of their latest guidance document, ISPE Good Practice Guide: Decommissi...
May 10, 2017
ISPE announced that CEO and President John Bournas was recognized as a top-10 Industry Influencer on The Medicine Maker’s 2017 Power List . The UK publication’s Power List celebrates 100 individuals “involved in bettering the pharma industry and brin...
May 05, 2017
ISPE released a new Cultural Excellence Report announced at its Conference on Quality Culture and Quality Metrics in Bethesda, Maryland, 25 April 2017. Cultural excellence recognizes quality not as an operational burden or compliance requirement, but...
April 12, 2017
ISPE announced the release of our latest guidance document ISPE GAMP® Guide: Records and Data Integrity . This guide provides an overview of principles and practical guidance on meeting current expectations for the management of GxP regulated records...
March 30, 2017
ISPE announced its fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference , taking place 5 – 7 June in Arlington, Virginia USA. This signature event features a series of concurrent workshops designed to facilitate open dialogue between pharmaceu...
March 15, 2017
ISPE announced its inaugural Pharmaceutical Serialization Workshops , taking place 8 – 9 May in Philadelphia, Pennsylvania USA. This unique event combines the benefits of a conference experience with ten interactive workshops covering baseline as wel...
February 27, 2017
ISPE announced its inaugural Conference on Quality Culture and Quality Metrics , taking place 25 – 26 April in Bethesda, Maryland USA. This uniquely focused event will feature high-level sessions, aligned with the FDA’s revised draft guidance on qual...