Expert Details

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

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. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization validation, and sterility assurance for the medical device and pharmaceutical manufacturing operations world-wide. He has held numerous technical and management roles with Alcon / Novartis, Johnson and Johnson, Isomedix, and Bristol Myers –Squibb for 25+ years. He holds a Bachelor of Sciences in Medical Technology from Texas State University and is certified by the American Society of Clinical Pathologists.

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

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Year Degree Subject Institution
Year: 1979 Degree: BS Subject: Medical Technology Institution: Texas State (Southwest Texas State at the time)

Work History

Years Employer Title Department Responsibilities
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.
Recent Projects:
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.

International Experience

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

Career Accomplishments

Associations / Societies
Licenses / Certifications
MT(ASCP) American Society of Clinical Pathologists
Professional Appointments
• 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

Fields of Expertise

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