If you are involved in any kind of regulated product manufacturing, knowledge of good documentation practices (GDP) is a must. Otherwise, you risk making costly errors and catching the unwanted attention of regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Join this session with expert speaker Dr. Afsaneh Motamed Khorasani for a basic- to intermediate-level discussion of the definition, purpose, and importance of GDP. In particular, Afsaneh will discuss GDP rules as they apply to laboratory notebook documentation. She will cover the U.S. Pharmacopeia General Chapter “Good Documentation Guidelines”. Further, she will provide an introduction to European Union (EU) GDP and its enforcement, along with some observation samples from the FDA.
This session will cover:
Who Should Attend
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- Dr. David Lim
Dr. Afsaneh Motamed Khorasani, Ph.D., is a medical and scientific affairs expert, and a senior scientist with a strong background in biomedical science and clinical trial/research. Afsaneh has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing, and intellectual property. She is currently the vice president of Medical Affairs at Easy Global Training, which...
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