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ISPE to Focus on ICH Quality Standards at 2011 Washington Conference

Article-ISPE to Focus on ICH Quality Standards at 2011 Washington Conference

ISPE, a global, not-for-profit association of more than 22,000 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, U.S., and Jonathan Walker, director manufacturing technology, Bristol-Myers Squibb, U.S., 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.

For a complete list of educational sessions and training courses, visit www.ispe.org/2011washingtonconference.

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