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CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman
CDRH has recently overhauled its Office of Compliance – what exactly has changed and what hasn’t? What does your team need to know going forward in order to deal with the Office of Compliance? What does the OC expect from you?
These are just a few of the important questions you need to ask. There is only so much you can learn from the diagrams and organizational charts provided by the FDA.
Order this exclusive question-and-answer webinar CD and transcript set with FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, as he speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help you understand all the changes.
With the recent reorganization of the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH), the office will sharpen its focus on international inspections and audits on labeling.
The office has also replaced the office’s former four–division structure with five divisions, with each division containing a number of sub-branches. The divisions are as follows:
Here’s who will benefit from your organization:
Meet Your Instructors
Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 170 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations. Mr. Silverman also represents CDRH on an agency-wide globalization initiative, and leads a Center-wide compliance strategic planning effort.
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs.
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