FDA KEYNOTE ADDRESS:
FDA’s Pharmaceutical Quality Assessment in the 21st Century – A Modern Risk-Based Approach Moheb Nasr, Ph.D., Director, Office of New Drug Quality Assessment, CDER, FDA
Pharmaceutical Technology magazine, the premier leader in cutting-edge information for the pharmaceutical industry, presents a case study driven conference orchestrated by an advisory board of highly respected experts. With R&D costs reaching astronomical levels in recent years, no one from a research scientist in an analytical lab to a QA manager in a manufacturing facility can afford to ignore the cost savings associated with achieving process excellence across the entire spectrum of drug development.
"It is almost like one stop shopping to anyone having to deal with Quality, become a Lean manufacturing machine,and look for new Technology that will help them get there…"
Jack R. Hoblitzell, Ph.D., Director, Formulations Development, Banner Pharmacaps
OPTIMIZE PROCESS EXCELLENCE:
– 30+ Case Studies and Presentations from FDA, Pfizer, Wyeth, Merck, AstraZeneca, Novartis, Schering-Plough, Boehringer Ingelheim, Bristol-Myers Squibb, and more
– Lean Design and Development Applications on ALL levels from R&D through Manufacturing including Six Sigma, Validation, Formulation Development, Clinical Supply Manufacturing, Pharmaceutical Processes, and Manufacturing Product Lines
– Pharmaceutical Quality Initiatives Quality by Design (QbD), ICH Q8, ICH Q9, Quality Systems, Process Analytical Technology (PAT), Design of Experiments (DOE), and Risk Assessment
– Cutting Edge Technology PAT, Ultra Performance Liquid Chromatography (UPLC), ScanRDI, Laser Induced Breakdown Technology (LIBS), Data Automation, Mathematical Modeling, and Process Transfer
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