* Agenda is subject to change.
Who Should Attend?
Management-level regulatory professionals who want a better understanding of employee management.
Nancy Singer is President of Compliance-Alliance LLC. She is on the faculty of George Washington University School of Medicine and Health Sciences. She presently teaches classes for FDA Staff Colleges and FDA District Offices, Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Susan Rolih is a quality assurance and regulatory consultant specializing in in vitro diagnostic devices (IVDDs). Previously, she served as executive and corporate vice president of global regulatory and quality systems for two US-based in vitro diagnostic companies. Rolih has extensive experience remediating quality systems and establishing regulatory strategies for IVDD and other life sciences companies. She has years of experience negotiating with foreign and US regulatory agencies, including the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA), the US Environmental Protection Agency (EPA), the US Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the European Union, Health Canada and others. Rolih has a master’s degree in immunohematology.
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Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.
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