SPI USA, Inc., Paris, France
March 22 and 23 , 2005
Seminar Topics
Introduction to cGMPs and the FDA
Quality Concepts; Organization of the Quality Unit
GLPs
cGMP Documentation; Validation Issues
Standard Operating Procedures and Batch Records
Gowning Procedures
Raw Materials, Laboratory and Process Control
Labeling & Identification
Cleaning; Cross-contamination Prevention
Inspections and Investigations
International cGMPs
New Trends in cGMP Compliance
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Invited Speakers:
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Dr. Antonio R. Moreira is Executive Vice President of SPI USA, Inc. and Vice Provost for Academic Affairs and Professor of Chemical and Biochemical Engineering at UMBC (University of Maryland, Baltimore County).
He was Chairman of the Chemical and Biochemical Engineering Department at UMBC from 1990 - 1995 and Associate Provost for Academic Affairs from 1995-1997. Prior to 1990, Dr. Moreira spent nearly ten years in the private sector, with management positions both in the food industry with International Flavors and Fragrances, Inc. and in the pharmaceutical/biotechnology area with Schering-Plough Corporation. He has significant experience with R&D, scale-up and introduction to commercialization of biotechnology products, such as alpha interferon.
Dr. Moreira holds a B.S. degree in Chemical Engineering from the University of Porto, Portugal, and M.S. and Ph.D. degree in Chemical and Biochemical Engineering from the University of Pennsylvania.
He has an active research program in bioprocess engineering and is a consultant to various biotechnology and pharmaceutical companies. He has received various awards including a NATO Senior Fellowship and the Halliburton Outstanding Young Faculty Award. He served as the President for the Chesapeake Bay Area Chapter of the International Society for Pharmaceutical and Medical Device Professionals; he is chair of the Council for Biotechnology Centers for the BIO Industry Organization, and serves on scientific advisory boards for various organizations. He is a graduate of Leadership Maryland, class of 1998.
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