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FDA initiated “Pharmaceutical Quality for the 21st Century” about 20 years ago. Janet Woodcock, then the Center Director for CDER challenged the pharmaceutical industry to develop: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.” In accordance with this “desired State”, ICH revised its quality vision emphasizing an integrated approach to quality risk management and science and embracing QbD to increase product and process understanding (ICH Q8 and Q11), application of risk management (ICH Q9), an effective pharmaceutical quality system (IH Q10), and most recently of pharmaceutical product lifecycle management (ICH Q12). In this QbD session, speakers from both industry and the FDA will provide a holistic overview of QbD and how QbD enhanced process and product understanding that alternately helped patients to access safe and effective, and high-quality biologics. A case study will be also presented followed by a panel discussion.