Virtual Product Responsibility Summit 2020: Recall Preparedness—What Do You Need To Know About FDA Recalls?
Recorded On: 09/18/2020
Recall preparedness is a must, but with the recent pivot to PPE, it is essential that member companies are up to speed on not only CPSC recalls, but also FDA recalls. The session with Neal Cohen, Kathleen Sanzo, and Lieutenant Commander Pamela Ogonowski will identify best practices and tactics to ensure you are prepared in the case you are required to execute a recall. This session will qualify as an elective for the Product Safety Awareness initiative.
Neal S. Cohen practices law in the area of consumer product safety before the U.S. Consumer Product Safety Commission (CPSC).
A former CPSC official, Neal brings a wealth of experience in representing companies before the CPSC. Not only does Neal have extensive knowledge of CPSC's safety requirements, he also understands how the CPSC and its staff really think when investigating a consumer product. With this knowledge and the relationships he has built in the product safety community, Neal works hard to represent the best interests of his clients in seeking a fair and favorable outcome.
Kathleen M. Sanzo centers her practice on regulatory and compliance issues connected to products regulated by the US Food and Drug Administration (FDA). She leads and counsels clients on matters relating to prescription, OTC drug, and biotechnology products clinical testing; food, dietary supplement, and cosmetic product manufacture, approval, marketing, and distribution; device promotion and labeling issues; food, drug, and device compliance matters; and all consumer product issues regulated by the US Consumer Product Safety Commission (CPSC) and state enforcement agencies.
Lieutenant Commander Pamela Ogonowski
Lieutenant Commander Pamela Ogonowski is a recall coordinator with the FDA’s Office of Strategic Planning and Operational Policy Division of Enforcement, where she serves as a subject matter expert in recalls. She joined FDA in 2009 as a consumer safety officer, conducting primarily food inspections. She then spent several years working as a division recall coordinator, ensuring that products in violation of FDA’s laws and regulations were promptly corrected or removed from the market. Prior to joining FDA, she worked as a medical laboratory scientist at a community hospital. She graduated from the University of New Hampshire in 2005 with a degree in medical laboratory science and she holds a graduate certificate in health management from the University of Massachusetts Lowell.
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