The Center for Professional Innovation & Education, Costa Mesa, CA
June 13-15, 2007
Who Should AttendThe course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings with the US FDA and similar European organizations. It will benefit professionals who are new to the pharmaceutical industry and also those who need refresher training. Learning Objectives Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice guidelines are in effect within their organization will have a thorough understanding of the current regulations (mandated by the USFDA and the International Conference on Harmonization), the necessity of rigorously implementing them in their groups, monitoring compliance in their and the collaborator’s organizations and incorporating this thinking in all scientific matters. The course will also discuss the consequences of non-compliance. Course Description This course is intended to give participants an introduction to Good Laboratory / Good Manufacturing Practice regulations and their application to laboratory studies and for manufacturing. This course will also provide participants with an understanding of terminology for laboratory studies and the role GLPs / GMPs play in assuring the validity of these studies. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.
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