Saturday, 18 October 2025

SDRAN/RAPS RAC Drug and Device Exam Practice Questions Workshop

DATE: Saturday, 18 October 2025

TIME:       RAC Drug Exam Practice Questions Session

08:00 AM -12:00 PM Pacific Time 

Networking Lunch 12:00 – 1:00 PM Pacific Time

RAC Device Exam Practice Questions Session

1:00 – 5:00 PM Pacific Time

LOCATION: MiraCosta College-Oceanside 

Aztlan A Conference Room (OC3450) | Building 3400

1 Barnard Drive, Oceanside, CA 92056

This event is also being offered virtually. The zoom link will be shared with you via email 1-2 days before the event.

Click here to register for this event.

Workshop Overview:

Prepare with confidence for your RAC Drug and Device exams! This workshop offers a comprehensive review of example RAC exam questions led by seasoned experts who have passed the RAC exams and designed official practice materials in recent years.

What to Expect:

• Proven test-taking strategies and study tips
• Insights from contributors to RAC practice exams
• Live review of practice exam questions with experienced professionals
• Q&A Panel Discussion
• Networking with subject matter experts and regulatory affairs colleagues

Whether you’re just starting your RAC prep or looking to refine your knowledge, this workshop is designed to give you a competitive edge.

This event is held at MiraCosta College-San Elijo campus at Cardiff, California.  In-person attendance is encouraged for those in the Southern California area.  Zoom attendance is available for those unable to attend in-person.

Event Agenda:

Click here to register for this event.

Registration Information:

For questions, please email: 

[email protected]

Registration Deadline:

Monday, 13 October 2025 11:59 PM Pacific Time

Click here to register for this event.

Panelist Biographies:

Tyler Vandivort, PhD, RAC, DABT 

Tyler Vandivort, PhD, RAC-Drugs, DABT is a board-certified toxicologist and regulatory affairs professional. He currently serves as a Regulatory Lead at UCB Biopharma where he focuses on the development of novel biologics for neurological and autoinflammatory diseases. He previously served as Director of Regulatory Affairs at Amplicore pharma, and has held various roles in the CRO space, including as a nonclinical regulatory consultant at Medpace, and as a GLP Immunotoxicologist at Charles River Laboratories. In addition to the American College of Toxicology and various mentoring organizations (City Tutors, Pathway for Patient Health), Tyler has been active with RAPS for a number of years. He contributed chapters 6-8 to the RAPS Global Fundamentals text, is currently on the Planning Committee for the annual RAPS Convergence conference (US), and has previously participated in authoring questions for the RAC-Drugs exam. From 2020 to 2023, he co-hosted the 2-day, quarterly workshop, “Preparing to Take the RAC-Drugs Exam” for RAPS. He joined the University of Cincinnati’s Masters of Pharmaceutical Science: Drug Development (MSDD) as an Adjunct Professor in 2023. 

Ajit Simh, MS 

Ajit has over 30 years of multidisciplinary experience in the medical device, chemical, pharmaceutical, and bio-pharmaceutical industry. He earned his bachelor’s degree in Biology and Chemistry from Bangalore University, India and his Master’s degree in Cell Biology from St. Louis University, St. Louis, Missouri. He has excellent technical knowledge in the manufacture and control of class I and II medical devices, drugs, biologics, and active pharmaceutical ingredients.

Ajit began his career with Mallinckrodt Medical and held increasingly senior positions in R&D, manufacturing, operations, and quality systems with Arena Pharmaceuticals, Cytel Corporation, Abbott Laboratories, Baxter Healthcare Corporation, and Cambridge Medical. Most recently he spearheaded the successful completion of a US FDA Pre-Approval Inspection (PAI) in Europe.

During his career, Ajit frequently interacted with the US FDA on inspections, submissions, and reviews of product applications. In addition, he shared the speaker’s panel with FDA and industry leaders at several national meetings in the areas of API’s, finished pharmaceuticals, and biologics. He has audited and advised companies within the US, Europe, Japan, China and India on operating in compliance with US FDA and ICH requirements.

In order to keep up with cutting edge technologies and current compliance trends, Ajit became an instructor at the University of California, San Diego in the biomedical-manufacturing program in 1994 and a member of the university advisory committee. He is also an adjunct professor at San Diego State University in the Regulatory Science graduate studies program offering a Master’s degree in Regulatory Affairs. He is a member of the advisory committee to the Bio-Pharm Journal, and affiliated with the Parenteral Drug Association (PDA) and IBC offering short courses in cGMP requirements and auditing foreign API manufacturers.

Natalie Kennel, FRAPS, RAC-US, ASQ CQE, CQMgr

Natalie founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs. With more than 35 years in industry, most devoted to medical devices, she has hands-on experience with development and manufacturing as well as RA/QA and clinical roles in both major and start up medical device companies. She applies her expertise to the regulatory, quality and clinical needs of medical device companies. Since forming her consulting business in 2005, she has submitted more than forty 510(k)’s, four de novo’s, more than 50 Pre-submissions (including pre-IDE’s), and several EUAs during the recent pandemic. The types of products cover both medical devices and in vitro diagnostic devices including, but not limited to, multiple orthopedic implants, intraocular lenses, infusion pumps, gynecological devices, ventilators, complex medical monitoring and neurology equipment, telemedicine devices, software only products, molecular diagnostic systems and assays for infectious diseases, human genetic testing and oncology, various clinical chemistry and immunoassays, and point of care lateral flow assays. Natalie has worked on several CDx and CTA’s for oncology products, a novel wound care device, and telemedicine device. She has set up quality systems for several different companies. She has provided on-going RA/QA for several companies. She has

prepared several international medical device submissions including for Canada, Australia, Europe,

Singapore, Taiwan, Saudi Arabia, and WHO. She has set up quality systems and provided regulatory

affairs support for a novel tissue bank. She has worked with several companies for the MDR and IVDR.

She published an article in AACC’s Clinical Laboratory News about the impact of the IVDR on clinical

laboratories in 2020 and spoke at AACC virtual meeting on this topic. She has been published in RAPS

regarding clinical trials for medical devices. She has spoken on multiple regulatory, quality and clinical

topics for SDRAN, ASQ and ACRP. She has taught the medical device section for the SDRAN RAC study group since 2002. She has taught a seminar regularly for the USC regulatory affairs master’s program on software validation. She has organized and chaired several SDRAN and SDRAN/OCRA events including on IVD’s, Corporate Compliance, and Supplier Interactions. She has previously been the President -Elect, President, and Vice President of Programs for San Diego Regulatory Affairs Network and is currently the President-Elect. She has been active in SDRAN since moving to San Diego in 2000. She holds a BS degree in Chemical Engineering from the University of Rochester. She can be reached at [email protected] .

Kim Walker, MS, RAC (US & EU), FRAPS

Kim Walker is an independent Global Regulatory Affairs, Quality System, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006.  In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system needs for IVDs, biologics, pharmaceuticals, dietary supplements, combination products, and medical devices.  

Kim has participated in the San Diego Regulatory Affairs Network (SDRAN) Mentoring Program since 2009 and on the Board of Directors since 2023 (2024 President).  She served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee 2003 – 2020 and on the Board of Directors 2004-2010 and 2019 (2008-2009 President).  Kim participated in the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3.  She currently teaches Regulatory Affairs courses for San Diego State University and Roseman University.  She is also the SDSU Center for Regulatory Science Faculty Director and Graduate Advisor.  Kim previously taught regulatory courses at CSUF and UCI and guest lectured at CSULA, UCSD, and Cal Poly Pomona.

She achieved both the US and EU RAC and is a RAPS Fellow.  Additionally, Kim received the 2008 RAPS Leonard Stauffer Award in recognition of her contributions to mentoring and furthering regulatory education development.  She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network, helping to bridge communication and collaboration opportunities between FDA and industry.  Kim received a lifetime membership award from OCRA in 2017 and SDRAN in 2022.  She has a BS in Bio-Medical Sciences and an MS in Regulatory Affairs.