Expert Details

Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP's

Expert ID: 730278 Alabama, USA

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Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and resolution, CAPA, CAPA related to specifically to sterilization, FMEA, FDA inspection and 483 response, and sterilization training.

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

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Education

Year Degree Subject Institution
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

Work History

Years Employer Title Department Responsibilities
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.

International Experience

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.

Career Accomplishments

Associations / Societies
AAMI, ASQ, PDA, IIA, IMRP
Professional Appointments
Program Co-Chair OC Device Alliance,
AAMI Executive Board,
AAMI Sterilization Standards Committee,
Co-Chair AAMI/TC 198 WG 2,
IMRP Program Committee

Additional Experience

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.
Vendor Selection
Selected vendors, audited vendors, developed supplier approval processes for the past 25 years.
Marketing Experience
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

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