Preparing to Take the RAC Devices Exam

6.0
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 11 October 2022 (5:00 PM) - Wednesday, 12 October 2022 (8:30 PM) Eastern Time (US & Canada)

Are you planning to take the RAC Devices Exam in 2022?

Join peers from the regulatory community for a workshop and study group designed to sharpen your critical, analytical, and strategic test-taking skills.

The sessions will be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.

During the workshop, faculty will review challenge questions similar to the style and content of the RAC Exam. This style of teaching has been used in other preparatory workshops and has been determined to be most useful for those taking the RAC Exam.

Important Notes:

Participation in this workshop should not be your only method of exam preparation. RAPS provides many exam preparation materials which can help you develop a comprehensive study plan.

*Registration for the Autumn RAC Window closes on 6 October 2022. The summer testing window runs from 31 October to 19 December 2022.

Pricing Amounts & Deadlines

08 April 2022 – 01 Sept 2022: Early Bird $495 Member | $580 Nonmember

02 Sept 2022 – 11 Oct 2022: Regular $580 Member | $680 Nonmember

Who Should Attend?

This workshop is designed for individuals planning to take the RAC Devices exam*. This is NOT a fundamentals course, and RAPS recommends attendees have a minimum of two to three years of regulatory experience and a thorough understanding of the regulatory profession.

Attendees will get the most out of this workshop if they already have a solid understanding of:

  • The full product development and lifecycle requirements for medical devices and IVDs
  • US FDA requirements
  • European regulations and guidances from the European Commission and Competent Authorities
  • Globally applicable regulatory practices, including ICH, IMDRF, WHO and ISO guidelines and standards

Agenda Coming Soon



 

Lead Faculty:

Anjali Atal-Gupta, M.Ed, RAC

Anjali Atal-Gupta, M.Ed, RAC is Associate Director, Regulatory Affairs at Novo Nordisk. In this role, she supports the development of global regulatory strategies for Novo Nordisk’s device delivery programs in its cell therapy R&D division. Previously, she worked at Stryker Corp. in its Neurovascular division managing US and EU Class III submissions and as a divisional process owner for EU MDR, as well contributing as an active member of International Organization for Standardization (ISO) and Advamed working groups. Prior to Stryker, she worked in both International and Domestic Regulatory Affairs at Boston Scientific on US Class III (neurovascular stent) and Class II products. Atal-Gupta started her medical device career in quality assurance at SMART Therapeutics. She has served in volunteer roles for RAPS for the past 15 years, including as speaker at RAPS’ annual Convergence and as a member of the Education, RAC Exam and Convergence Program committees. She has earned her Regulatory Affairs Certification (RAC US, EU and Device) and is also a Certified Quality Auditor (CQA).

Presenters:

Elizabeth Bereza

Elizabeth Bereza is a regulatory affairs specialist at Microline Surgical Inc. She is involved in all areas of regulatory within the company, including premarket and postmarket activities, and quality system compliance. Bereza earned the RAC-Devices as well as Certified Medical Device Auditor status in 2019. She has a master’s degree in regulatory affairs from Northeastern University in Boston, and has worked in regulated industries for 18 years.

Leslie Cort, RAC, PMP

Leslie Cort, RAC, PMP is a Regulatory Business Process Program Manager for Global Regulatory Shared Services (GRSS) at Medtronic, where she leads functional and Enterprise-level programs and initiatives. Through-out her career, she has worked in Regulatory Affairs and supported a broad range of medical devices with experience in new product development, sustaining, international regulatory affairs and regulatory submissions.

Leslie’s educational background includes an undergraduate degree in Chemistry from Savannah State University, and a Master’s Degree from Northeastern University in Regulatory Affairs of Drugs, Biologics and Medical Devices. Leslie has served in volunteer roles at RAPS as a committee member for the RAC Devices Exam. In addition, she received the Regulatory Affairs Certifications, (US and Devices) from the Regulatory Affairs Professionals Society.

Stephanie Seidel, RAC

Stephanie Seidel, RAC is the Sr. Principal Clinical Evaluation Specialist at Medtronic. She has over 25 years of progressive and diverse experience in the medical device industry, including 20+ years of scientific and technical communication, and 16+ years in regulatory and clinical affairs. Expertise includes Class I, II/IIa/IIb, III devices, including multi-product systems. Active and passive implantable devices, software, wireless accessories, surgical tools and electromechanical hardware. Device expertise includes cochlear implant systems, peripheral vascular, neuromodulation and blood processing devices. Authored or collaborated on 125+ approved U.S. and international regulatory submissions in over 90 markets, including for Class III (high-risk) medical devices. Senior clinical evaluation strategist for the EU, China and other global markets.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to support@raps.org. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Call RAPS Support Center at +1 301.770.2920, Ext 200 or email workshops@raps.org.

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