Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
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.
Upon the conclusion of the program, you will be able to:
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.
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.
Dr. Shirk has 10 years of regulatory writing experience, as well as 8 years of experience in pharmaceutical drug discovery research and 13 years in clinical laboratory science. In her current position at Synchrogenix, Dr. Shirk writes and reviews a variety of nonclinical and clinical regulatory documents for both small-molecule drugs and biologics. Dr. Shirk also leads nonclinical writing teams for regulatory submissions, serving as a liaison between the writers, client, and management; maintaining collaborative and effective communications with sponsor and internal team; and providing guidance and subject matter expertise reviews.