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Date: 7th - 9th July, 2008

Location: Malvern, PA, USA

Summary:
Pharmaceutical - Training, Seminar

Who Should Attend
The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, cosmetics, pharmaceutical and agrochemicals industries who need a comprehensive overview of the requirements of the FDA's current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) mandates.

Personnel whose job function necessitates the generation, evaluation and assurance of data from pre-clinical studies will find this class particularly useful. It will also be beneficial to anyone responsible for regulatory filings with the US FDA and corresponding organizations overseas. Professionals who are new to the pharmaceutical industry as well as those who need refresher training will find this course equally useful. Participants working as quality assurance and quality control managers, regulatory affairs professionals, auditors, production managers or management interested in effective compliance techniques will find this course relevant.

Learning Objectives
By the end of the course, attendees will have a strong understanding of the compliance requirements for current Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines, and be able to apply compliance protocols in all efforts aimed at generating regulated data. All participants will gain a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them in their groups, and incorporating this regimen and proactive thinking in all scientific matters. The consequences of non-compliance will be exemplified.

Course Description
This course is intended to give participants an introduction to Good Laboratory Practice and Good Manufacturing Practice regulations and their application to laboratory studies and manufacturing. This course will 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 need for thorough and comprehensive training and documentation.