Adiuvo is highly regarded in the medical device and sterilization industries. Areas of expertise include: quality systems development and assessment, radiation and EO sterilization validation, sterilization management, medical device regulations, supplier auditing, nonconformity investigation and resolution, FMEA, FDA inspection and 483 response, and training.
Adiuvo QS & SA Consulting will offer 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, Adiuvo QS & SA Consulting 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.”
Adiuvo service lines are unique on several counts. First, Lisa Foster,
Principal, 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.
Adiuvo also presents a full complement of laboratory services to
enhance speed and convenience due to the relationship with SteriPro Labs.
Customers who are most appropriate for Adiuvo QS & SA services,
- Large manufacturers who do not wish to maintain, or plan to reduce, Sterility Assurance
or Quality Assurance (SA/QA) staff in order to trim the cost of manufacturing.
- Medium to small manufacturers with limited SA/QA personnel, limited technical knowledge
of the sterilization process, or those who cannot afford the time needed to support
the sterilization process.
- Medium to large manufacturers with limited personnel to monitor and audit key suppliers
to the manufacturing process.
- Small or start-up manufacturers who lack the staff to perform the sterilization
studies needed to get product to market or clinical trial or develop the quality
system needed to obtain regulatory and ISO certification.
- Pharmaceutical manufacturers who desire to convert to terminal sterilization vs.
conventional aseptic processing, or those developing new products in need of terminal
sterilization or enhancement to the aseptic process.
- Manufacturers in need of training related to sterilization in order to better manage
their contract sterilizer.
Principal, Adiuvo QS & SA Consulting
Lisa Foster began her medical device career at Sterigenics International in 1989.
Throughout her tenure, she has held Quality Assurance positions at the facility
and the corporate levels.
- In 1997, Ms. Foster was named Vice President of Quality Assurance for Sterigenics,
the world’s leading supplier of sterilization and ionization services for the medical
- In 2002, she was promoted to Vice President of Quality Assurance for Ion Beam Applications
(IBA), then parent company of Sterigenics. In this position, Ms. Foster was responsible
for designing and implementing quality systems throughout IBA’s worldwide network
of cancer therapy medical devices and sterilization technologies.
- From 2004-2010, she served as Vice President of SteriPro® Services. This division
of Sterigenics International includes two value-added service offerings, SteriPro
Consulting and SteriPro Labs.
Ms. Foster is actively involved in industry committees, task forces and working
- She is an Executive Committee Member of the Association for the Advancement of Medical
Instrumentation (AAMI) Sterilization Standards Board (invitation only) and serves
on the AAMI Sterilization Standards Committee (invitation only).
- She serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization
- She has served as co-chair for the AAMI Radiation Process Control Task Group, which
developed TIR 29, Guide for Process Control in Radiation Sterilization during her
- She is also an active member of several other AAMI sterilization working groups.
- In addition, Ms. Foster has been a presenter at numerous industry and FDA training
seminars throughout the United States.
- Ms. Foster holds a Bachelor of Science in Food and Nutrition from Mississippi University
for Women and a Master’s of Science in Food Technology from Mississippi State University.
Ms. Foster’s areas of expertise include: quality systems implementation and management,
sterilization validation, regulatory compliance, FMEA, Six Sigma, FDA inspection,
auditing, and radiation safety.
“As your consulting partner, it’s my responsibility to understand your goals and
help achieve your vision. Your success is my success.”