FOR IMMEDIATE RELEASE
—Conference to consist of seven sessions, three training courses designed to help participants deliver cost-effective GMP solutions—
(TAMPA, FLORIDA, USA, 11 May 2011) – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced today that it will feature seven educational sessions, including two sessions that will focus on ICH quality standards, as part of its 2011 Washington Conference, which will take place 6-9 June 2011 at the JW Marriott in Washington DC, USA.
ICH Q8, Q9, and Q10 will be a primary focus of Addressing ICH - Robust Process Validation and Compliance Assurance Starts with Product Realization: Effectively Applying Quality by Design (PQLI®), a fundamental-to-intermediate level session which will take place 6-7 June. This session will highlight the business value of applying Quality by Design (QbD) principles and the risks that occur when QbD is not in place. This session will also help participants use related ISPE Good Practice Guides to implement QbD in their companies. Sponsored by the ISPE PQLI Committee, the session will be led by Roger Nosal, Vice President of Global Chemistry, Manufacturing Controls, Pfizer Inc, USA and Christopher Sinko, Vice President, Bristol-Myers Squibb, USA, and will feature presentations by a number of pharmaceutical industry experts and prominent members of the PQLI Committee.
Are You Ready for ICH Q11? Emerging Topics in the API Global Regulatory Environment will focus on ICH Q11 and will take place on 8-9 June. This intermediate-to-advanced session will feature Industry and Regulatory members of the ICH Q11 Expert Working Group who have authored the guideline to provide background on the origins of Q11, the key concepts contained in the guideline, and the progress made towards harmonization. The session, which will be led by Catherine Dubuisson-Brengel, Assistant Director, Global Regulatory Affairs, Sanofi-Avantis, USA, and Jonathan Walker, Director Manufacturing Technology, Bristol-Myers Squibb, USA, will prepare participants to provide informed comments on the ICH Q11 guideline when it is published for public review, incorporate principles from the guidance into the development and lifecycle management of manufacturing processes for drug substances, and adopt a QbD submission to the Common Technical Document format.
Other educational sessions will include:
In addition to the educational content being presented, the 2011 Washington Conference will feature three training courses:
Complete session agendas and training course outlines for the 2011 Washington Conference are available on the ISPE Web site. To register for the conference, visit www.ISPE.org/2011WashingtonConference, or call ISPE Member Services at +1-813-960-2105. For press passes to attend this event, contact Danielle Hould, ISPE Communications Manager, by telephone at +1-813-960-2105 or via email at email@example.com.
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” 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.