Since 1998 experience as an independent consultant in the areas of sterilization, microbiology and compliance to the medical device and pharmaceutical industry. This experience has included the following:
Serving as a technical advisor or Microbiologist to review sterilization, environmental monitoring, microbiological testing (including pyrogens), and cleaning programs/practices both for new, ongoing, and changes to manufacturing processes.
Serving as a technical advisor to companies and new product development teams in areas of sterilization standards and biological requirements.
Serving as a technical advisor and validation coordinator to medical device and pharmaceutical companies for radiation sterilization of raw material components, drug devices, and medical devices.
Serving as a technical advisor and validation coordinator to medical device companies for EO sterilization of new, revised, or existing devices to validate, revalidate, or optimize their EO sterilization process utilizing process equivalency, conventional or parametric release.
Conducting documentation reviews of procedures and validation files for medical device and pharmaceutical companies providing a summary of necessary improvements, rewriting procedures and completing final reports.
Conducting sterilization, environmental, and microbiology laboratory assessments for medical device/pharmaceutical companies with recommendations for GMP/GLP compliance and best practices.
Conducting audits to determine conformance with United States Quality System Regulations, ISO 9000 and EN 46000 of contract sterilization and laboratory facilities.
Developing cleaning validation plans.
Developing a quality manual to be in compliance with current Quality System Regulations.
Assisting companies in responding to the FDA following/duing inspections.
Developing plans and rationales for product families, frequency of testing, and the establishment of the appropriate sterilization dose for medical device and pharmaceutical products.
Conducting training courses on ethylene oxide, radiation or steam sterilization, laboratory testing, principles for controlled environments, and other aspects related to microbiological control in the production of medical devices.
Serving as Co-chair of the AAMI working group for ethylene oxide which includes representing the United States at ISO.
Served as co-chair of AAMI task group assigned with the task to develop a Technical Information Report on product adoption and process equivalency for ethylene oxide sterilization.
Served as member of AAMI task group charged with the development of a Technical Information Report on a new method for substantiation of 25 kGy as a sterilization dose.
Served as member of AAMI task group assigned to the development of a Technical Information Report on the Microbiological Aspects of EO sterilization.
Over ten (10) years experience in the supervision and management of a laboratory and sterilization services group. Responsibilities included employee relations, annual and capital budgets up to $2 million, training related to sterilization, GMP, and laboratory practices, commissioning and validation, preventive maintenance, relocation of testing, support to R&D and manufacturing, inventory control and customer service.
Expertise in validation and implementation of ethylene oxide and radiation (gamma & e-beam) sterilization programs for such products as intravenous catheters, long line or mid line catheters, wound dressings, gloves, garments, procedural kits, sponges, and pharmaceutical raw materials.
Project Manager for ethylene oxide sterilization relocation from in-house sterilization to contract sterilization.
Provide Internal and Supplier Audits in conformance with United States Quality System Regulations, ISO 9000 and EN 46000. Auditing experience includes Contract Sterilization, Laboratory Services and Environmental Assessment of manufacturing operations for medical devices.
Expertise in viable and non-viable environmental monitoring programs for laboratory and manufacturing facilities.
Served on HIMA task group to develop industry response and course of action to address Pyronema domesticum.
Coordinated development of internal ethylene oxide standards for Fortune 100 Healthcare Company.
Developed validation program for medical device manufacturing and laboratory facility cleaning operations.
Established and managed laboratory operations that served as a central testing facility for independent divisions of Fortune 100 Healthcare Company. Testing that was provided included bioburden, cytotoxicity, decontamination of returned complaints, EO residuals, LAL, particulate, sterility, microbial barrier and the sterilization of R&D materials. This resulted in excess of $200,000 income for the laboratory on an annual basis.
Laboratory expertise includes procedure development and validation, cleaning and equipment validation and steam sterilization validation, as well as various testing capabilities.
Advised medical device facility in the areas of sterilization, pyrogenicity, toxicity, bioburden, environmental controls and biological complaints.
Project Manager to obtain ISO/EN registration for laboratory services. Received registration with no observations on the initial assessment.
Served as sterilization and laboratory liaison for FDA inspections, ISO/EN Assessments, and Internal Audits.
Advised and established acceptable practices and standards for the handling and processing of contaminated medical device complaint samples.
Established validation program for validation of sterilization process for contaminated medical devices.
Served as representative on J&J Medical Global Technical Service Team to develop long term plan for coordination and provision of technical services for J&J Medical facilities worldwide.
Provided assessment of alternate forms of sterilization for use with particular medical device.
Worked with overseas contract sterilization facilities to ensure compliance to internal standards for acceptable sterilization validation.
Project Manager for ethylene oxide sterilization cycle optimization program that reduced inventory by several days resulting in a one-time cost savings of approximately $200,000 and an annual savings of approximately $20,000.
Provided laboratory service to medical device facility to decontaminate complaint samples that provided compliance to OSHA requirements and helped them to reduce investigative time from months to days.
Established residual testing capabilities within the sterilization and laboratory group by setting up the Gas Chromatography system and conducting the necessary testing.
Managed laboratory operations that supported testing associated with alternate forms of sterilization such as dry heat, hydrogen peroxide-plasma, and propylene oxide.
Managed laboratory operations that included stability testing of products and materials; analytical and physical testing of raw materials, finished products, and complaint samples; and package integrity testing and design of primary, secondary and tertiary packaging.
Developed and validated a computer record-keeping process using a database system for the laboratory reports and approved supplier list.
Project Manager for implementation of product and component particulate testing program in support to environmental monitoring.
J&J Signature of Quality Examiner in 1993. Operated on a team of examiners to a J&J company in a process that is an internal version of the Malcolm Baldrige National Quality Award.
Registered Microbiologist, 1983 - present - National Registry of Microbiologists. Registered in the area of Consumer Products & Quality Assurance
