[Mr.] Shirley H. Isbill
Lawrenceville, NJ
Cell #: 609-218-0609
gcpsolutions@verizon.net

I was previously a Supervisory Investigator assigned to the North Brunswick, NJ office of FDA. I have over 16 years of field investigation experience and over 20 years experience as a supervisor.

I spent the last 10 years conducting audits of clinical investigation facilities in the U.S., Canada, Germany, Finland, England and other countries.       [Complete Resume]

I supervised other FDA Investigators who conducted similar audits in New Jersey and foreign countries.

I was FDA's Bioresearch Program Manager in New Jersey. My duties involved scheduling inspections and audits of drug companies who plan new drug trials, Investigational Review Boards who approve the trials, CROs who monitor the trials and clinical investigators who conduct the trials.

I evaluated FDA inspection reports to determine if any violations found warranted official agency action such as a Warning Letter or disqualification.

I have a B.S. degree in Biology from Carson-Newman College Jefferson City, TN and I have attended multiple training courses involving FDA regulated processes and products.

I have participated in internal audits of FDA district office functions in Minneapolis and Baltimore. I taught FDA investigators in Florida and Minneapolis how to use FDA's computer software to develop reports of FDA inspections. Most recently, I presented this training at FDA's Advanced Bioresearch Training Course with specific emphasis on clinical study site inspections.

Updated: October 13, 2006