Orange County


Welcome to the SOCRA Orange County Chapter page. Information for the latest meeting is below. If you have any questions, please reach out to the Chapter Chairperson or the SOCRA office at office@socra.org.


Orange County Chapter Meeting Announcement

Date:                March 10, 2020

Time:               4:30-5:30 PM

Location:         University of California Irvine
                          843 Health Sciences Road
                         Irvine, CA 92617

Room:               Hewitt Hall, Room #1042

Topic:                How to Handle a FDA Inspection: Expectations,
                           Outcomes, & Consequences    

Speaker:            Michael Hamrell, PhD                  

Dr. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs and Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has worked for over 5 years at the FDA and 3 years at the NIH coordinating the development of drugs, biologics, and vaccine products for AIDS, oncology, and anti-infectives.

Dr. Hamrell has a PhD in Pharmacology from the University of Southern California.

Dr. Hamrell holds an appointment as Adjunct Professor of Molecular Pharmacology and Toxicology at the University of Southern California School of Pharmacy and as Adjunct Associate Professor at four other reputable universities.

Dr. Hamrell has served on the Editorial Board of Regulatory Affairs FOCUS and Applied Clinical Trials. He currently serves on the Editorial Board of Clinical Trials Advisor, Applied Clinical Trials and The ACRP Monitor and is the past Editor-in-Chief of the Drug Information Journal and former Editor-in-Chief of the DIA Forum. He is also the Editor-in-Chief of the GCP Q&A Reference Guide published by Barnett International. 

Overview/Objectives:  

  • Discuss how FDA selects research sites for an inspection
  • What outcomes result from an inspection
  • Do's and Don't for a successful inspection

CE:      SOCRA members may claim 1 CE for attending. SOCRA members will receive a certificate of attendance.

Parking:           There will be a parking fee

RSVP:               Maribelle Guloy, DHSc, CCRP,  guloymaribelle@gmail.com

Please share this announcement with your colleagues.

Chapter Chairperson:
Maribelle Guloy, CCRP
Phone: 323 724 8769
guloymaribelle@gmail.com
Email