Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP's
Expert ID: 730278 Alabama, USA
Ms. Expert began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Expert has held various quality assurance positions at both the facility and Corporate levels where she served as Sterigenics Vice President of Quality Assurance from (Undisclosed) and as Vice President SteriPro Labs & Consulting from (Undisclosed). Ms. Expert is an Executive Committee Member of the AAMI Sterilization Standards Board (invitation only), a member of the AAMI Sterilization Standards Committee (invitation only), serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization Working Group, has served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization, and is also an active member of several other AAMI Sterilization Working groups. Ms. Expert has been a presenter at numerous industry and FDA training seminars throughout the United States. She holds a Bachelor of Science in Food and Nutrition from Mississippi University for Women and a Masters of Science in Food Technology from Mississippi State University.
Expert's consulting company offers customers practical consultative programs designed to enhance your firm’s quality system, regulatory compliance, and sterilization practices. A unique blend of consultative analysis, technical assistance and laboratory support from Sterigenics SteriPro Labs, her consulting company is “specifically designed to enhance quality systems, provide practical solutions to manufacturing and sterilization issues, and provide consulting services to the customer that will lead to the customer’s self reliance.” Expert's service lines are unique on several counts. First, Expert served as Sterigenics Vice President of Quality Assurance for 15 years, the largest contract sterilizer in the world, and seven years as Vice President of Laboratory and Consulting services, providing customers the benefit of her experience, know-how and technology of the world pacesetter in medical sterilization. Secondly, She presents a full complement of laboratory services to enhance speed and convenience due to the relationship with SteriPro Labs.
Her reputation in the sterilization industry is unquestionable, and provides expert the ability to get client sterilization management issues resolved quickly and effectively.
Expert may consult nationally and internationally, and is also local to the following cities: Mobile, Alabama - Gulfport, Mississippi - Biloxi, Mississippi - Pensacola, Florida
|Year: 1984||Degree: Master of Science||Subject: Food Science & Technology||Institution: Mississippi State University|
|Year: 1982||Degree: Bachelor of Science||Subject: Food & Nutrition||Institution: Mississippi University for Women|
|Years: 2011 to Present||Employer: Undisclosed||Title: Owner||Department:||Responsibilities: Is the Principal and founder|
|Years: 2004 to 2011||Employer: Sterigenics||Title: V.P. SteriPro||Department: Laboratory/Consulting||Responsibilities: Executive responsibility for the laboratory and Sterilization Consulting division|
|Years: 1989 to 2004||Employer: STERIGENICS INTERNATIONAL||Title: V.P. QA||Department: QA/RA||Responsibilities: Developed and implemented quality system for 28 facilities owned and operated.|
|Years: 1986 to 1989||Employer: STERIGENICS INTERNATIONAL||Title: Director QA||Department: QA||Responsibilities: Responsible for quality management at contract manufacturer of fats and oils.|
|Years: 1984 to 1986||Employer: STERIGENICS INTERNATIONAL||Title: Manager||Department: QA||Responsibilities: Responsible for quality control testing and management of core product production lines.|
|Years||Country / Region||Summary|
|Years: to Present||Country / Region: Thailand||Summary: Started up irradiation facility in Thailand. Spent 6 months performing Iq/OQ/PQ.|
|Years: to Present||Country / Region: Denmark||Summary: Several months in Denmark trouble shooting quality and sterilization processing issues at irradiation facility.|
|Years: to Present||Country / Region: Taiwan||Summary: Performed IQ/OQ/PQ at start up irradiation facility.|
|Years: to Present||Country / Region: Europe||Summary: Developed Global Quality System for all countries under Sterigenics ownership. Including: USA, Canada, Mexico, Thailand, China, UK, Belgium, France, Germany, Denmark.|
|Associations / Societies|
|AAMI, ASQ, PDA, IIA, IMRP|
|Program Co-Chair OC Device Alliance,
AAMI Executive Board,
AAMI Sterilization Standards Committee,
Co-Chair AAMI/TC 198 WG 2,
IMRP Program Committee
|Training / Seminars|
|Provided Industrial Sterilization seminars for the past 20 years.
Speaker and trainer for FDA regarding sterilization.
Course teacher for AAMI Industrial Sterilization seminars.
Developed many seminars for industry over the past 10 years.
Recently developed seminar: Application of CAPA for Sterilization.
|Selected vendors, audited vendors, developed supplier approval processes for the past 25 years.|
|Expert is considered one of the top 10 leaders in industrial sterilization in North America.|
|Other Relevant Experience|
|Expert provides a practical approach to not only sterilization but to quality system development, SOP's, auditing. and general manufacturing practices.|
Fields of Expertise
electron beam, electron-beam sterilization, ethylene oxide, ethylene oxide sterilization, gamma radiation, gamma radiation effect on plastic, gamma-ray sterilization, gas sterilization, industrial sterilization, ionizing radiation, irradiation, ISO 9000 series quality system standard, medical device, medical device inspection, medical device irradiation sterilization, medical device manufacturing quality control, medical device sterilization, medical polymer sterilization, medical sterilization, plastic irradiation, quality, quality assurance, quality assurance management system, quality assurance project plan, quality auditing, quality control, quality evaluation, quality improvement, quality management, quality standard, sterile, sterility assurance level, sterilization, sterilization processing technology, sterilizer, supplier quality assurance, terminal sterilization, manufacturing quality assurance, laboratory quality assurance, manufacturing quality control, medical device packaging standard, medical device packaging material, bioburden, medical package, medical device product development, sterilization packaging technology, gamma-stable plastic material, medical waste gamma irradiation process, medical device manufacturing, polymeric material sterilization, medical polymer