How to Prepare for a Regulatory Inspection: Planning for Success
Program Speaker:
Ajit Simh
SVP Global Drug Compliance at Arcturus Therapeutics Inc.
Adjunct professor at SDSU and UCSD
Event Agenda:
DATE: Monday, September 15 2025
TIME:
6:00 – 6:15 PM Welcome and Announcements
6:15 – 6:35 PM How to Prepare for a Regulatory Inspection
6:35 – 6:55 PM Import Process Overview
6:55 – 7:15 PM Q&A
7:15 – 7:30 PM Wrap Up
LOCATION: This event is being offered virtually.
The zoom link will be shared with you 1-2 days before the event.
- Click here to register for this event to attend VIRTUALLY.
Presentation Topic Title: How to Prepare for a Regulatory Inspection: Planning for Success
This presentation will provide a practical guide to understanding the purpose of Pre-Approval Inspections (PAIs) and the strategies necessary to ensure a successful outcome. Through real-world examples, Ajit will highlight common challenges and effective solutions for preparing for both GMP and Clinical (BIMO) inspections, with a focus on first-time PAIs.
Speaker Biographies:
Ajit Simh brings over 30 years of experience in the biopharmaceutical industry, specializing in active pharmaceutical ingredients (APIs), biologics (recombinant proteins and vaccines), oral solid dosage forms, ointments, parenterals, and medical devices.
He has led and hosted numerous GMP and BIMO Pre-Approval Inspection (PAI) preparedness activities in the U.S. and internationally. Most recently, Ajit has collaborated with regulatory agencies including the EMA, HPRA, and PMDA to support successful inspections.
In addition to his industry work, Ajit has been actively engaged in academia since the mid-1990s. He has served as an adjunct faculty member in the graduate program at San Diego State University and as an instructor at the University of California, San Diego, where he has also contributed to advisory boards.
Registration Information:
- Register for the event here
Contact
Pricing – Online – Registration (ends Sunday, September 14, 2025)
| Registrant Type | virtual event price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member | $20.00 | |
Cancellation Policy
There will be no refunds for cancellations.
Laura Guy, MS, RAC, earned a BS in Psychobiology from UCLA and an MS in Regulatory Affairs from SDSU. Her Company, Regulatory Liaisons, LLC provides Regulatory Affairs and Quality System services to innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, medical devices (including IVDs) and combination products. To support her clients, Ms. Guy establishes infrastructures that promote compliance with FDA/ISO/ICH/MDR regulations and standards.
Kim Walker is an independent Global Regulatory, Quality, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006 with over 30 years of industry experience. She is active in non-profits, serving on the board of directors and various committees, and has managed, moderated, and presented at several professional conferences. Kim has been an SDRAN Mentoring Committee volunteer since 2009 and RAC Study Group presenter since 2014. She is a current instructor at SDSU and Roseman University and past instructor at UCI and CSUF for both graduate and undergraduate level regulatory courses.
Daniel Yeh, RAC, has over ten years of experience in the Development, Manufacturing, and Commercialization of medical devices. In his current role as the Director of Regulatory and Quality at MedWaves Inc., Daniel is managing new product submissions as well as maintaining international registrations.
His regulatory work includes 510(k) submissions, managing the quality system, and responding to FDA and ISO audits. Outside of quality, he also oversees product development and manages clinical activities including distributor sales, product training and other medical affairs.
Azita Hedayati is a Regulatory professional with experience in quality assurance, regulatory affairs, and program management, having spent over two decades in leadership roles within the medical device and healthcare sectors.
Most recently, Azita served as the Sr. Quality Systems Program Manager at Medtronic, where she managed quality initiatives at the Northridge facility. Prior to that, she was the Sr. Director of Regulatory Affairs and Quality Assurance at eVent Medical, overseeing regulatory and quality compliance for medical products at the company’s Lake Forest office.
Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to clinical development and FDA approval. She has held various roles in preclinical research, Clinical Trial Management, Regulatory Affairs, and Project Management. She is currently a Project Manager at Navigate BioPharma Services Inc., a Novartis subsidiary. Olivia received her Doctorate in Biomedical Sciences from the University of California, San Diego and her Bachelor's Degree in Biochemistry/Molecular Biology from the University of California, Santa Barbara.
Jingrui (Jing) brings over 6 years of invaluable experience in the pharmaceutical and medical device industries, specializing as a design control/design quality engineer. With her expertise, she has successfully led numerous projects involving drug/device combination products, in vitro diagnostic devices (IVD), companion diagnostic products, and Software as a Medical Device (SaMD) products. Serving as a design control project lead, she has effectively provided both project management and technical leadership to ensure strict compliance with U.S. FDA medical device regulations (21 CFR 820) as well as international standards such as ISO 13485, ISO 14971, IEC 62304, 62366, EU MDR> and IVDR.
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