How to Prepare for a Regulatory Inspection: Planning for Success

by | | SDRAN Events

 

 

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 

[email protected] 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

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