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Active Pharmaceutical Ingredient (API) and Drug Product Specification

September 29, 2008

Pharma Development and Business

The Center for Professional Innovation & Education, Costa Mesa, CA January 26-28, 2009 Who Should Attend This comprehensive three-day course will be valuable to R&D personnel involved with all regulatory filings from IND to NDA. This would include Process Development Chemists preparing GMP API for clinical use as well as Analytical Chemists in stability sample testing, general analytical testing and method development. Personnel in Regulatory Affairs, Quality Assurance, and the Quality Control laboratories who are involved in testing, supervising, or managing all GMP/GLP activities will also benefit, including those whose job responsibilities require an in-depth knowledge of the FDA regulations and ICH guidelines, as applied to establishing regulatory specifications. Learning Objectives This course provides a step-by-step foundation for determining specifications for Active Pharmaceutical Ingredient (API), Raw Materials, Intermediates, Drug Products, Excipients and Placebos. Curriculum will outline and detail the issues and guidelines surrounding FDA and ICH regulatory requirements. Specifically, this course will focus on learning the protocols needed to establish the specifications required to support all levels of development. Attendees are actively engaged through the use of workshops and in-depth discussion, including exercises on writing and revising specifications and the stability data required to support these specifications. Course Description This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to prepare and maintain specifications from the early stages of product development and throughout the product life cycle. Among the topics to be discussed will be: Identifying FDA’s regulations and ICH guidelines for specifications Preparing and maintaining specifications for Active Pharmaceutical Ingredient (API) Raw Materials Intermediates Drug Products Excipients and Placebo to ensure that they comply with FDA and ICH requirements Additional benefits of this class include: Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. Cumulatively, the course directors have over 50 years of industry experience

Organized by:			Center for Professional Innovation & Education
Invited Speakers:			info@cfpie.com

Deadline for Abstracts:			n/a

Registration:			http://www.cfpie.com/showitem.aspx?productid=011&source=hummolgen
E-mail:			info@cfpie.com

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