FOR IMMEDIATE RELEASE
ISPE Announces Release of Baseline Guide®, Risk-MaPP
Conferences, webinars, training, and white papers augment document release
(TAMPA, FLORIDA, USA, 3 June 2010) – ISPE, a global not-for-profit association of 24,000 pharmaceutical science and manufacturing professionals, announces the much-anticipated release of the Baseline Guide® Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP) to be available third quarter 2010. Attendees to select ISPE conference events will receive a complimentary copy of the Guide as soon as it is available.
Opportunities to understand the “why,” “what,” and “how to use” the Guide include conferences, webinars, training, and white papers. Educational sessions pertaining to Risk-MaPP, offered during a series of conferences led by the Guide authors, will focus on use of the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination, and formulating a Quality Risk Management Plan as part of a Quality System. Attendees will hear directly from companies that have implemented Risk-MaPP principals in several case studies.
A Live Webinar entitled, “Risk-MaPP: What Is It and Why You Need It,” will be held on 14 September as an introduction for professionals not yet familiar with, or who seek a better understanding of, the importance of Risk-MaPP. The webinar is a prerequisite to upcoming conference sessions, and should be attended by conference delegates for maximum understanding. A recorded version of the webinar will also be available in late September.
Upcoming conference events featuring Risk-MaPP include:
Additionally, ISPE is developing an intensive Risk-MaPP training course to be available second quarter 2011.
An ISPE Risk-MaPP Knowledge Brief and the Risk-MaPP team white paper to the EMEA ( 38 KB) on the need for updated GMP guidance concerning dedicated facilities provide further information about the subject.
For more information on Risk-MaPP, visit MaPP.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 24,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.