FOR IMMEDIATE RELEASE
ISPE Hosts Risk-MaPP Conference “Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach” Featuring the North American Launch of the New ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Attendees Receive Complimentary Copy of Guide
TAMPA, FL, USA; 3 September 2010 – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced today that it will host the ISPE Risk-MaPP 2010 Conference, Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach, the site of the North American launch of the new ISPE Baseline® Guide: Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP), in Washington, D.C., USA on 4-5 October 2010. Attendees of the conference will receive a complimentary downloadable copy of the new Guide prior to the event. Conference attendees will also receive a complimentary registration to a webinar entitled “Risk-MaPP: What is it and Why You Need it!”
Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, the Guide is an essential tool in understanding and controlling the risk of cross contamination, while also protecting the operator.
Conference leaders Stephanie Wilkins, PE, President, PharmaConsult US Inc., and Bruce Naumann, PhD, DABT, Director Occupational Environmental Toxicology, Merck & Co., Inc., along with other Guide authors, will focus on the 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 two case studies. For complete conference education information, or to register for the ISPE 2010 Risk-MaPP Conference.
For conference attendees and those purchasing the Guide separately, the live webinar, “Risk-MaPP: What is it and Why You Need it!” on 14 September 2010, provides an opportunity to understand the basics of “why,” “what,” and “why you need” the new Risk-MaPP Guide.
Additional upcoming conferences featuring Risk-MaPP include:
ISPE is also developing an intensive Risk-MaPP training course to be available second quarter 2011.
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.
FDA Office of Pharmaceutical Quality Initiatives & 2016 Priorities
Friday, 24 Jun 2016 12.06
Interdisciplinary Perspectives on Key Pharma Industry Trends
Thursday, 23 Jun 2016 15.06
Endless Opportunities to Expand Your Knowledge & Network
Wednesday, 22 Jun 2016 12.06