Experience:
Gerry O’Dell Consulting
President, 1998 - present - Consult in the areas of sterilization, laboratory and other related compliance areas for medical devices, biologics and pharmaceuticals.
Johnson & Johnson Medical
Manager Laboratory & Sterilization Services, 1994 -1998 - Manager of laboratory and sterilization group that included sterilization, microbiology, analytical, packaging, stability and physical testing for JJM and other J&J companies.
Critikon, Inc. (a Johnson & Johnson Company)
Manager Sterilization Services, 1990-1994 - Manager of sterilization and microbiology group that supported routine and new product development.
Supervisor Sterilization Services, 1988-1990 - Supervised the microbiology group. Instituted computerization that resulted in 25% reduction in errors.
Assistant Sterilization Scientist, 1985-1988 - Validated sterilization operations, conducted study to reduce BI testing time by 50% and set up in-house residual testing.
Microbiology Lab Technician, 1983-1985
Education:
M.S. in Microbiology, University of South Florida, 1985
B.A. in Microbiology, University of South Florida, 1980
Assessment to EN46000 and Medical Device Directive, 1995
GMP and ISO 9001 Requirements of Medical Devices, 1995
Signature of Quality Examiner Training, 1993
Quality Control in Manufacturing, 1990
Microbiological Aspects of Process Validation, 1988
EtO & Radiation Sterilization Techniques, 1986
Statistical Process Control, 1985
Affiliations and Accreditations:
Registered Microbiologist, 1983 -present
Member, American Society for Microbiology, 1984 - present
Member, Association for the Advancement of Medical Instrumentation, 1985 - present
J&J Medical Global Technical Service Team, 1996-1997
J&J Signature of Quality Examiner, 1993
Member, U.S. Sub-TAG for ISO/TC 198/WG 1 (Industrial Ethylene Oxide Sterilization)
Member of the following AAMI Sterilization Standards Committee Working Groups
Industrial Ethylene Oxide Sterilization (AAMI/ST/WG 01), Co-chair since 2006
Radiation Sterilization (AAMI/ST/WG 02)
Industrial Moist Heat Sterilization (AAMI/ST/WG 03)
Microbiological Methods (AAMI/ST/WG 08)
General Criteria for Sterilization Processes (AAMI/ST/WG 11)
Dry Heat Sterilization (AAMI/ST/WG 42)
Sterilization Residuals (AAMI/ST/WG 63)
Sterility Assurance Level (SAL) (AAMI/ST/WG 90)
Cleaning of Reusable Medical Devices (AAMI/ST/WG 93)
Rigid Sterilization Container Systems (AAMI/ST/WG 94)
Compatibility of Materials Subject to Sterilization (AAMI/ST/WG 96)
Publications/Training Programs:
Lead Instructor – AAMI Course “Industrial Ethylene Oxide Sterilization for Medical Devices”
Instructor as Subject Matter Expert in Sterilization, Biocompatibility, Controlled Environments and Laboratory Testing – ASQ CBA Review Course
Co-Instructor – AAMI Webinar – “EO Sterilization: Comparison of 1994 and 2007 versions of ANSI/AAMI/ISO 11135-1”
Co-Instructor – AAMI Webinar – “EO Sterilization: Guidance on the Application of ANSI/AAMI/ISO 11135-1”
Instructor for the following Compliance Online Webinars
“Basics of testing associated with sterilization validation and routine processing”
“Ethylene Oxide (EO) Sterilization Basics for R&D Engineers”
“Failure or OOS Investigation for Environmental Monitoring”
“Failure or OOS Investigation for Sterility or Bioburden Testing”
“How to investigate environmental monitoring excursions”
“You have a sterility or bioburden test failure – Now what?”
Author - “How to Conduct and Document a Microbiological Failure Investigation”, July 1998 - The Validation Consultant.
Co-Author - “Industry Responds to Pyronema domesticum: HIMA Screening Studies”, September 1997 - Medical Device & Diagnostics Industry.
