Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) 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.

The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical and pharmaceutical 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 also benefit professionals who are new to the pharmaceutical industry and also those who need refresher training.