Northern California Chapter FDA's Bioresearch Monitoring Programs
Stuart W. Russell, D.C.
CSO/Investigator
FDA Pacific Region, SF District
Thursday March 11, 2010 6:00 – 9:00 PM
Your clinical site is about to be inspected by the FDA - what will happen and what will the inspector look for? The risk model used to select sites for inspection and data on recent BIMO (Bioresearch Monitoring) Program inspection findings in the US and internationally will be discussed. The incidence of scientific misconduct and fraud and specific detection techniques including statistical methods will be described and illustrated with case studies. Methods for detecting and preventing scientific misconduct and fraud as well as the FDA complaint handling system will also be reviewed. Bring your questions to this great opportunity to meet with an FDA inspector!
Stuart W. Russell, D.C.
Dr. Russell is an FDA inspector specializing in Bioresearch Clinical Monitoring. He primarily inspects domestic sites but is also a member of the International Inspection Team. He additionally assures GLP and GMP practices are followed per the US CFRs for Pharmaceutical manufacturing facilities, Tissue and Reproductive facilities, and Blood and Plasma facilities.
Dr. Russell earned his BS at Pepperdine University and his graduate Chiropractic degree at Los Angeles College of Chiropractic / S CA University of Health Sciences. Other areas of study include clinical orthopedics, biofeedback, nutrition, herbal, and homeopathy. He is retired from his chiropractic practice. Prior to joining the FDA, Dr. Russell was the National Manager/Formulator/Technical Writer for a Homeopathic, Herbal and Vitamin company, and has lectured nationwide in that capacity and authored multiple magazine articles and a book entitled, "Professional Complementary Combination Prescribing, A Desk Reference for the Herbal Practitioner" (not currently in publication).
“Of all the work I do for the federal government, I find the most rewarding to be clinical research inspectional audits. This area of work ensures safe and effective drugs and devices come to market fulfilling a public need and I typically develop a relationship with the clinical investigator and staff to improve the research process.”
Agenda:
6:00 – 7:00 PM: Registration sign-in, Networking, & Dinner Buffet
7.00 – 7.30 PM: President's Welcome, Certificates of Appreciation, Door Prize, Announcements
7.30 – 8.50 PM: Presentation
8.50 - 9.00 PM: Q&A
Target Audience:
Clinical Research Professionals
Sponsor Organizations
Study Site Investigators & Coordinators
Independent Consultants
Students of Clinical Research
Academic Medical/Clinical Researchers
Service Providers/Vendors
Institutional Review Boards
Quality Assurance
EVENT REGISTRATION before Monday, 08 March 2010 11:59PM PST
Register early to assure admission; at event IF space available(+$5.00 nonmember)
REGISTER at https://www.avectraacrp.com/eWeb/DynamicPage.aspx?WebCode=LoginRequired&...
– or click http://acrpnet.org/Northern CA Chapter
NCC ACRP member Free
ACRP member $10
Non-member $15
Event registration and contact hour purchase information:
NCC ACRP policy: No refunds or transfers.
Membership not required for online registration/purchase.
You will receive an email confirmation upon successful registration/purchase - please print and bring to the event.
ACRP will provide you with updated contact hour information once the approval is complete.
To receive purchased contact hours: sign-in at event, attend entire event, and complete the automatically generated online evaluation form 10-24 days after the meeting.
Directions to Gilead Sciences, Inc.
From 101 South (San Francisco/SFO Airport) or 101 North (San Jose/Palo Alto)
Take the 3rd Avenue exit going East (3rd Avenue becomes J. Hart Clinton Drive).
Turn right onto Lakeside Drive.
Destination: on the right -NW corner of campus -Lakeside & J. Hart Clinton Drive
From 92 westbound take the Foster City Blvd. exit
Turn left onto Chess Drive.
Turn right onto Vintage Park Drive.
Turn left onto Lakeside Drive.
Destination: on the left- NW corner of campus on Lakeside & J. Hart Clinton Drive
Online registration/CEU purchase questions: Megan Markowski at megan@acrpnet.org
Event questions: Renisa Satrijo at rsatrijo@gmail.com
In-kind support provided by Gilead Sciences, Inc.
This activity is provided by unrestricted educational grants from UC Berkeley Extension & Idem Translations
