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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This webcast will introduce participants to the FDA's Accreditation Scheme for Conformity Assessment, or ASCA, a program in which manufacturers may contract with ASCA-accredited test labs to perform testing to certain consensus standards, reducing the burden and streamlining the conformity assessment elements of device review.
Participants will be able to: (1) outline the ASCA program and its benefits and (2) describe the three elements of ASCA testing results in a device submission.
Regulatory affairs and standards professionals
Stacy Cho is a senior policy analyst with the Standards and Conformity Assessment Program (S-CAP) at the Center for Devices and Radiological Health. Stacy received her B.S. in Biological Sciences and Psychology from Carnegie Mellon University and received her M.A. in Psychological and Brain Sciences with a focus on fMRI studies from Johns Hopkins University. Stacy started her career at FDA in 2013 after spending several years as a neurophysiologist with hospitals in the DC metro area. At FDA, she served as a lead reviewer for radiological devices with premarket, compliance, and postmarket submissions; and she also led the Third Party 510(k) Premarket Program. Currently, she is the Accreditation Body Lead for the Accreditation Scheme for Conformity Assessment (ASCA) program after spending several years establishing the program.
Shireen Fotelargias is a Senior Policy Analyst in the Standards and Conformity Assessment Program (S-CAP) in the FDA’s Center for Devices and Radiological Health. She currently leads the internal education and training programs for the Accreditation Scheme for Conformity Assessment (ASCA) across the Center. Shireen also served as a Regulatory Health Program Manager for the FDA’s Center for Tobacco Products where she was a member of the review team that evaluated and implemented administrative and regulatory action in relation to scientific submissions for tobacco products. Before joining FDA, she was a Biosafety Specialist for the University of Maryland where she performed reviews of applications for authorization to conduct work with recombinant DNA, infectious agents, gene therapy and human materials. She received her B.S. in Biological Sciences from North Carolina State University and earned her M.S. in Biotechnology with a specialization in Biosecurity and Biodefense.
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