[Mr.] Shirley H. Isbill

5 Camelia Court Lawrenceville, NJ 08648

Cell: 609-218-0609  Email: gcpsolutions@verizon.net

Web Site: http://mysite.verizon.net/sisbill1/gcp.htm

Post-FDA Activities

GCP Associate Consultant: Phoenix Regulatory Associates, Ltd
Member: Capitol Health Systems IRB Trenton, NJ
Member: St. Mary Medical Center IRB Langhorne, PA

Data integrity investigation - Medical Device Study - July & August 2006
Data verification audits - Breast Implants - June/July 2007

FDA Employment History

·        FDA Investigator with 16 years field experience and more than 20 years of supervisory experience regulating marketed foods, drugs and medical devices.  My last 10 years involved drug and device clinical research audits.

·        Excellent computer skills using MS Excel, Word and HTML.  

 

FDA Supervisor, Satellite Inspection Office, North Brunswick, NJ                    1981- Jan 2006

FDA Supervisor, Satellite Inspection Office, Edison, NJ                                      1977-1981     

FDA Supervisor, New Jersey District Office, East Orange, NJ                           1976-1977

FDA Investigator, Satellite Inspection Office, Trenton, NJ                                  1970-1976      

FDA Investigator, St. Louis Inspection Station, St. Louis, MO                            1968-1970        

FDA Investigator, Cincinnati District Office, Cincinnati, OH                              1964-1968

 

Domestic Inspection Experience

 

·        The investigation of non-clinical studies of Flagel, Copper-7 IUD and Aspartame which identified the need for promulgation of GLP Regulations.  He received the FDA Group Award of Merit and was nominated as Chief Monitor and Coordinator for authentication of Aspartame studies (1975)

·        Inspections of  medical device, drug, food and cosmetic manufacturers as well as FDA audits of non-clinical drug studies in Canada and in New Jersey (1976 - 1995)

·        FDA audits of clinical investigator studies of new drugs and devices; inspections of CROs and clinical study sponsors (1994 - present)

  

Foreign Clinical Study Auditing Experience

 

Finland, Belgium, Sweden                            angioplastic procedures                                October 1995              

Finland, Slovenia                                                         bioequivalence studies                                           March 1996

Germany                                                                           leukemia chemotherapy                                May 1997                      

England                                                                             hemophilia studies                                         July 1998

Canada                                                                              endometriosis studies                                                November 1998

Germany                                                                           defibrillator studies                                       June 1999

Holland & England                                       arthritis treatment                                         January 2000

Germany                                                                           children's vaccines                                         April 2000

Canada                                                                              bioequivalence studies                                   December 2000

Canada                                                                              cryoablation studies                                      December 2003

Jordan                                                                                bioequivalence studies                                   December 2003

England, Germany                                        congestive heart failure study                      June 2004

Belgium                                                                             infertility study                                              June 2004

 

Supervisory Experience

 

·        Act as an advisor to FDA's New Jersey bioresearch investigators.  Schedule inspection coverage for Sponsors, Monitors, CROs, IRBs and Clinical Investigators. Clinical trial audit reports are reviewed to determine if adequate inspection coverage was provided, if findings represent violations, and if adequate documentation was collected to support agency action. (1994 – present)

·        Managed FDA's Investigation Branch in Philadelphia (1995),  Los Angeles (1993), and Newark (1986), for 30 days each

·        Developed and maintained a database inspection assignment tracking systems for FDA's Newark and Philadelphia Districts;  developed Warning Letter reinspection tracking systems for Newark and Philadelphia;  developed audit procedures to insure the accuracy of drug and medical device company profile records;  developed a Standard Operating Procedure for mass seizure of foods stored under unsanitary conditions (1986 – 1994)

·        Among the best qualified for selection to the position of Director, Investigations Branch in Philadelphia (1996), Newark (1993), Baltimore, Buffalo, Cincinnati, Chicago and FDA's Division of Field Investigations (headquarters)  

·        Successfully completed a variety of personnel actions involving conduct violations and job performance deficiencies (1976 – 1999)

·        Presented training to FDA investigators regarding computerized development of the list of violations presented to a firm at the conclusion of an inspection and FDA inspection reports: MN, FL, Rockville, MD (2000 – 2004)

·        Internal audits of FDA regulatory operations: Minneapolis (2002), Baltimore (2004)

 

Education

 

Carson-Newman College                                                                  Jefferson City, TN

B.S. Biology, Pre-Med Curriculum                                                 1964

 

Temple University School of Law                                                   Philadelphia, PA  

FDA Law, Product Liability (6 Credits)                                         1972

 

Mercer County Community College                                               Hamilton Township, NJ

Computer Science (12 Credits)                                                        1993

 

Military Service

 

None; Father killed July 1944 after Normandy Invasion

 [Updated: November, 2006]