ISPE Risk-maPP conference attendees to receive new Baseline Guide

Attendees will hear from companies that have implemented Risk-MaPP principals, receive downloadable copy of Guide.

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ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will host the ISPE Risk-MaPP 2010 Conference, Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach. At the Oct. 4-5 event in Washington, DC, ISPE will present the North American launch of the new ISPE Baseline® Guide: Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP).

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. The Guide serves as a 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 conference attendees and those purchasing the Guide separately, the live webinar, “Risk-MaPP: What is it and Why You Need it!” Sept. 14 provides an opportunity to understand the basics of “why,” “what,” and “why you need it” regarding the new Risk-MaPP Guide.

ISPE is also developing an intensive Risk-MaPP training course to be available second quarter 2011. Additional Risk-MaPP resources can be found at
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