White Papers, Articles, Video

White Papers

The State of the Biotechnology Industry Today 2011

This concise study provided by Plunkett Research includes analysis by Ernst & Young, IMS Health, the U.S. Centers for Medicare & Medicaid Services (CMS), FDA, the drug industry association PhRMA and the Tufts Center for the Study of Drug Development, and others.

It includes an overview on common drug application categories and commentary on stem cell research, global factors boosting biotech today, patents and drug development costs and FDA programs, human clinical trials, and the role of emerging nations and ethical issues.   All rights reserved (c) copyright, Plunkett Research, 2011.

Videos

GMP for Pharmaceutical Manufacturing and Testing

GLP/cGMP Instrument Compliancy: A Bit of the Wild West and How to Avoid Shooting from the Hip

Good Manufacturing Practice or cGMP are practices and systems used in pharmaceutical manufacturing, quality control, and quality systems covering the manufacturing and testing of pharmaceuticals.

The ultimate goal of cGMP practice is production of data that is accurate and reliable.

In this introductory presentation, Vito Grisanti, a veteran with over 27 years in the industry, introduces fundamental principles, practices and the benefits of Qualifications (IQ, OQ, PQ) and Compliance Services of laboratory mass spectrometry and chromatography instrumentation, commonly used with CRO, CMO and Life Sciences laboratories.