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Purity is a Virtue: A Practical Guide to the Reporting of Impurities
オンデマンド・ウェビナー

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various types of impurity and then delve into each of the guidance documents. To demonstrate application of this knowledge, we will present a few relevant case studies in which impurities were successfully investigated and reported in marketing applications.

Speakers

Nellie Forwood, MS, RAC, CQE, Principal Regulatory Writer, Synchrogenix

Ms. Forwood has over 30 years of experience in the pharmaceutical and other regulated products industry (pre- and post-approval) as a Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs Professional. She is a certified Six Sigma Master Black Belt with proven expertise in the use of Six Sigma Define, Measure, Analyze, Improve, and Control tools to improve processes and implement and maintain improvements. Ms. Forwood has written various types of pharmaceutical CMC and clinical regulatory documents.

Angela Howard, PhD, DABT, Regulatory Writer II, Synchrogenix

Dr. Howard is a board-certified toxicologist with experience in analyzing human and animal toxicology studies to develop health hazard and dose-response assessments in the areas of environmental and consumer/personal care product risk assessment. She has been involved in the evaluation and use of in vitro and in silico methods to support the safety of regulated products in the consumer sector. Dr. Howard has contributed to nonclinical written and tabulated summaries of small molecule drugs and biologics for submission to the FDA.

Rebecca Shirk, PhD, Principal Regulatory Writer, Synchrogenix

Dr. Howard is a board-certified toxicologist with experience in analyzing human and animal toxicology studies to develop health hazard and dose-response assessments in the areas of environmental and consumer/personal care product risk assessment. She has been involved in the evaluation and use of in vitro and in silico methods to support the safety of regulated products in the consumer sector. Dr. Howard has contributed to nonclinical written and tabulated summaries of small molecule drugs and biologics for submission to the FDA.

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