Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
Expert ID: 733713 Texas, USA
He is the current Co-Chair of the AAMI WG1 Ethylene Oxide working group and actively participates in the Aseptic Processing, Radiation, Moist Heat, Dry Heat, Microbiology Methods and Sterilization Residuals working groups. He has been a representative and US expert for U.S. Sub-TAG for ISO/TC 198 working groups for Dry Heat sterilization and Aseptic Processing. Jeff currently participates and represents the US on the Ethylene Oxide and Moist Heat ISO/TC 198 working groups. He is a member of PDA, and ISPE.
Expert may consult nationally and internationally, and is also local to the following cities: Fort Worth, Texas - Dallas, Texas
|Year: 1979||Degree: BS||Subject: Medical Technology||Institution: Texas State (Southwest Texas State at the time)|
|Years: 2016 to Present||Employer: Undisclosed||Title: President and Principal Consultant||Department:||Responsibilities: President and Principal Consultant 6/3/2016 — Current
- Independent and contract based consulting to medical device and pharmaceutical companies in meeting regulatory requirements and mitigating audit observations, regulatory and validation issues.
o Aseptic Processing validation, SIP validation, risk assessment for environmental monitoring, mitigation and corrective actions of environmental and personnel practices for FDA warning letter
o Container Closure Integrity Testing Validation, Disinfectant Efficacy Validation, Swab Sampling Recovery Validation
o Combination product ethylene oxide sterilization validation, stability and 2X sterilization.
o OTC drug manufacturer CGMP assessment in preparation for FDA audit, environmental controls, process validation, mixing and cleaning validation, inspection and test method validation
o Ethylene oxide process and equipment validation, Process Equivalence, Parametric Release,
o Moist Heat process assessment, Steam Air Mixture, and water cascade sterilizers - IQ/OQ and PQ of Biological & Physical Qualification, BI determination, BI / Bioburden Approach
o R&D sterilizer purchase, installation, process development for Ethylene Oxide
o BSL- 3 safety assessment - facilities, personnel practices, process safety and security
o Medical Device Ethylene Oxide process residual limits and reduction
o Packaging equipment IO/OQ/PQ, test selection, sample size, process window determination
o Medical Device Product and packaging shelf-life studies
o EO Process re-qualification BI Failure investigation and root cause analysis
|Years: 2004 to 2016||Employer: Alcon a Novartis company, Fort Worth Texas||Title: Director Corporate Quality Technology||Department: Corporate Quality Technology||Responsibilities: Responsible for sterility assurance and validation practices for all Alcon business units (Surgical, Pharmaceutical, Vision Care) for 23 manufacturing sites facilities world-wide, Maintain best practice and requirements for sterilization, aseptic processing, clean rooms, controlled environments and cleaning validations
- Recognized corporate leader and consulting member of the following - Novartis Sterility Assurance Expert Network, Medical Device Expert Network, and Microbiology Expert Network. Member of Novartis Key Opinion Leaders on external standards and regulations.
- Mentor and leader for development of site competencies in sterilization validations, process validations, facility validations and environmental control.
|Years: 1997 to 2004||Employer: Johnson and Johnson - Ethicon Endo Surgery||Title: Manager Sterility Assurance, Sterilization Science and Environmental Services||Department: Opertions||Responsibilities: Responsible for the sterilization of internal and contract manufactured products worldwide.
o Operational, financial, and environmental compliance for the J&J EES gamma irradiators - Manage eight direct reports in technical validation operations, and a group of 25+associates. Interfaces with manufacturing, R&D, franchise development, and business development.
|Years: 1994 to 1996||Employer: 3M - RCM Converters Inc., El Paso, Texas||Title: General Manager of Technical Services||Department: Technical Services||Responsibilities: Departmental responsibilities for Quality, and Materials Management, Production Planning, Engineering, and Product Development. Led company efforts in developing systems for ISO 9001 certification, MRP system procurement and implementation, facilities and clean rooms. RCM Converters Inc. was a 3M incubator business.|
|Years: 1991 to 1994||Employer: ISOMEDIX INC., Whippany NJ.; Spartanburg, SC.; El Paso, Texas||Title: Corporate Director QA/RA, Quality Assurance Manager, Operations Manager||Department: Quality and Operations||Responsibilities:
Responsible for EO and gamma irradiation qualifications, validations and operations for a large number of customers utilizing both ethylene oxide and radiation sterilization technologies
|Years: 1989 to 1991||Employer: ARGON MEDICAL a Bristol Myers Company; Athens, Texas||Title: Supervisor QA Microbiology/Sterilization||Department: Quality / Sterilizer Operations||Responsibilities: Responsible for internal EO sterilizer validations and operations, microbiology and chemistry labs.
|Years||Country / Region||Summary|
|Years: 2018 to 2018||Country / Region: Vietnam||Summary: Consulting for process development and troubleshooting of Water Cascade and Ethylene Oxide sterilizers and processes|
|Years: 2017 to Present||Country / Region: Japan||Summary: Consulting for Compliance assessments and Warning letter remediation for Aseptically Produced product and OTC Products|
|Associations / Societies|
|PDA, AAMI, ISPE|
|Licenses / Certifications|
|MT(ASCP) American Society of Clinical Pathologists|
|• AAMI/ST/WG 01, Industrial EO sterilization WG – Co-Chair and US expert to ISO / TC198
• AAMI/ST/WG 02, Radiation sterilization WG - member
• AAMI/ST/WG 03, Industrial moist heat sterilization WG – US expert to ISO/ TC 198 WG3
• AAMI/ST/WG 09, Aseptic processing WG - member and former US expert to ISO/ TC 198 WG9
• AAMI/ST/WG 12, Instructions for reusable device reprocessing - member
• AAMI/ST/WG 42, Dry heat sterilization WG – US expert to ISO/ TC 198 WG 14
• AAMI/ST/WG 63, Sterilization residuals WG - member
• AAMI/ST/WG 93, Cleaning of reusable medical devices - member
• AAMI/ST/WG 96, Compatibility of materials subject to sterilization – member and prior Co-chair for development and revision of the AAMI TIR 17 - 2008
|Publications and Patents Summary|
|Co-author of the sterilization chapter of Biomaterials Science 3rd edition Elsevier Academic Press|