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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This interactive session, featuring an FDA medical device reviewer and an FDA 510(k) and Device Determination Program expert, focuses on the three most important areas of 510(k) submissions, and how to avoid administrative and regulatory holds. This session will also feature renowned industry professionals who specialize in Software as medical devices, RA/QA/clinical strategy as well as a 510(k) reviewer from the FDA’s Third Party Review Program.
This is a hybrid event, offering both on-site and remote options, using state of the art flex classroom technology from the University California-Santa Cruz’s Silicon Valley extension. Attendees can log in from anywhere in the world and feel like they are physically in the same room as in-person attendees. An in-person networking session with the speakers and industry professionals, as well as a Q&A, will follow the presentation.
The University of California- Santa Cruz, Silicon Valley Extension and the RAPS San Francisco Bay Area chapter are sponsoring this knowledge-sharing and community-development event. RAC holders may claim two recertification credits for attending.
Appetizers will be served at the in-person portion.
February 24, 2023 — April 12, 2023 $35 member | $45 nonmember | $25 student
Through the lens of the FDA, industry professionals, and the FDA’s 510(k) Third Party Review Program, participants will:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. 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.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Professionals with strong knowledge of the topic(s) and/or demonstrated well-developed regulatory technical knowledge and skills. Typical job titles at this level – RA specialist, RA managers, reviewers, compliance experts.
Professionals well-versed in most/all concepts associated with the topic(s) and who are involved in translating knowledge into effective plans and strategy. Professionals who work with other teams (research and development, marketing) throughout product lifecycle and focus on bringing devices to market faster. Typical job titles at this level include, director, vice president, CEO, supervisory reviewer, and branch chief.
RAPS San Francisco Bay Area Chapter Hybrid Event: Top 3 Mistakes to Avoid in Your510(k) Submission to the FDA or Third Party
Michael E. AdjodhaM.ChE., CQIA | Supervisory Chemical Engineer | Assistant Director| Center for Devices and Radiological Health (CDRH) | U.S. Food and Drug Administration (FDA)
Michael has 29 years of experience as an engineer in the Federal Government, including 25 years with FDA’s Center for Devices and Radiological Health. His experience includes 22 years as a medical device reviewer of dental devices with FDA, and experience as a project manager with the U.S. Nuclear Regulatory Commission, and a Patent Examiner with the U.S. Patent and Trademark Office. As a reviewer for FDA, Michael reviewed over 1000 510(k) submissions for dental restorative and prosthetic devices, evaluated numerous 513(g) classification requests and PMA 30-day notices, and provided SME support to FDA field offices regarding compliance and enforcement actions. He also authored or co-authored several device-specific guidance documents, including dental composite resins, dental amalgam, noble metal alloys, base metal alloys, bone grafting materials, light activators, oral scanners for CAD/CAM, temporary mandibular condyle devices, and denture base resins. His work also involved preparing responses to Citizen Petitions and developing environmental assessments for agency-initiated actions. Currently, he supervises the Restorative and Surgical Dental Devices Team within the Division of Dental and ENT Devices with CDRH where he provides oversight and direction for reviews and decisions on 510(k), IDE, De Novo, Q-Sub, and 513(g) submissions.
Melissa HallPolicy Analyst | 510(k), De Novo, 513(g), Device Determinations & Custom Devices Lifecycle Team | Office of Regulatory Programs (ORP) | Office of Product Evaluation and Quality (OPEQ) | Center for Devices and Radiological Health (CDRH) | U.S. Food and Drug Administration (FDA)
Melissa Hall is currently a 510(k), 513(g), Device Determination Program Expert in the Office of Regulatory Programs (ORP) within the Center for Devices and Radiological Health (CDRH). Her work focuses primarily on interpreting, updating, and developing policy related to both 510(k) and 513(g) submissions. In addition, she serves as the lead for the CDRH Third Party 510(k) program.
Melissa began her career at FDA in 2013 as a lead reviewer focused primarily on the review of spinal devices. She then served as the Assistant Director for the Spinal Devices Division within CDRH providing leadership and serving as an expert in the guidance, regulation, and review of spinal devices. Prior to her current role she worked as a consumer safety officer in the Division of Industry and Consumer Education (DICE) educating external stakeholders about the various regulatory resources and requirements established by FDA.
Before joining the FDA, Ms. Hall worked at the USPTO reviewing orthopedic devices patents. She received her Master of Science in Biomedical Engineering at the New Jersey Institution of Technology (NJIT), and a Bachelor of Science in Biological Sciences from the University of Maryland Baltimore County (UMBC).
Stephanie M. FittsPhD | Vice President, Global Quality and Regulatory Affairs at Align Technology
Stephanie is the Vice President, Global Quality and Regulatory Affairs, at Align Technology, a global medical device company focused on dental devices. She has served in this role since 2019 and leads the global regulatory and quality functions for all manufacturing sites and business units.
Prior to Align, Stephanie served as Vice President at TransEnterix, Inc., a medical device company focused on the use of robotics to improve minimally invasive surgery. Here, she was responsible for global strategy and management of regulatory affairs, clinical research, and quality assurance programs. Stephanie previously served in Regulatory and Quality leadership positions Baxano Surgical, Inc. (formerly TranS1, Inc.), Stryker Orthopedics and Medtronic, Inc.
Stephanie earned a PhD in Bioengineering from Pennsylvania State University and a BS in Engineering Science from the University of Virginia.
Prabhu RaghavanMS, MBA | Principal Consultant, MDQR Solutions | UCSC Extension Instructor, SaMD
Prabhu is a quality and regulatory professional with over 20 years of experience in medical devices and has held senior leadership positions in both startups and large organizations. He is currently the Principal Consultant at MDQR Solutions, boutique consulting company focusing on providing regulatory affairs and quality engineering services for medical device startups. He is also an instructor for regulatory affairs at University of California, Santa Cruz. Previously, he was the VP of Regulatory and Quality at AliveCor, a startup utilizing artificial intelligence to help patients manage their arrhythmia. Prior to AliveCor, Prabhu was an executive at Jan Medical, a startup focused on noninvasively detecting brain abnormalities, and at Stryker, where he held several senior leadership roles in regulatory affairs and quality assurance. Prabhu started his career developing machine learning algorithms at Bell Laboratories. Prabhu has 5 issued patents. He has a Master of Science in Electrical Engineering from Rutgers University and a joint MBA from University of California, Berkeley/Columbia University.
Prithul BomCEO, Regulatory Technology Services (RTS) Third Party Review Organization (3PRO) | PhD Candidate
I have 22 years of healthcare, medical device, biotech and IVD industry experience, starting with my career as a software developer in 1998 at Lawson Software, Infor. In addition to software development (Infor), I have served in Business Development (Johnson & Johnson, RCRI, WMDO), Scientific Affairs and Global Head of Regulatory Affairs (Theorem, Chiltern), and Executive Strategist - Medical Device & Diagnostics (Covance, Labcorp). My managerial experience includes managing regulatory scientists in Asia, Europe and North America. I have authored and or managed numerous 510(k), IDEs, de novos, and clinical development plans / protocols. I have led and or supported numerous FDA meetings which include Q-submissions, and pre-IND and IDE meetings. As the Executive Lead, I have overseen numerous Phase I-IV clinical studies (radionuclides, contrast media). My specific scientific and regulatory experience since 2013 has been in general imaging modalities including reviewing 510(k) and managing diagnostic contrast agents and radionuclides studies for MR, PET, SPECT, X-ray, CT, Ultrasound, EEG, and Near Infrared.
Surina GulatiSenior Quality Systems & Compliance Engineer at Align Technology | RAPS SF Chapter Leadership
Surina has over 5 years of quality and regulatory experience in the medical device industry. She currently serves as a member on the SF RAPS Chapter Leadership team. Surina works as a Senior Quality Systems Engineer at Align Technology Inc. Prior to Align, Surina worked for a Stanford StartX AI/ML Medical Device Start-up after completing her MS from Johns Hopkins University in Biotechnology & Entrepreneurship. Surina started her career at Thermo Fisher Scientific, in the BioProduction Division after graduating from University of California Berkeley.
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