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Purity is a Virtue: A Practical Guide to the Reporting of Impurities

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Purity is a Virtue: A Practical Guide to the Reporting of Impurities

This is an On-demand recording from April 2021


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

Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. These basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Learning Objectives

Upon the conclusion of the program, you will be able to:

  • Understand the different types of impurities in DS and DP
  • Understand how impurities are handled per regulations and regulatory guidance
  • Understand decision trees for identification and qualification of impurities
  • Review examples of impurity qualification studies

Who Should Attend?

  • CMC Regulatory Affairs
  • Nonclinical Regulatory Affairs
  • Regulatory Affairs Consultants/Scientists
  • Regulatory/Medical writers

Speakers

Nellie Forwood

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

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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