The QB1 of GLP

In this episode, our hosts are joined by the QB1 (or 4 of them) of GLP (Good Laboratory Practice), NAMSA’s Study Directors. Throughout this podcast, the team delves into the role of the Study Director in biocompatibility and chemical characterization studies, discussing day-to-day activities, legalities, key factors manufacturers should know about working with a Study Director and the qualifications needed to be an effective Study Director.

Discussion points include:

• GLP and what it means for biocompatibility studies
• The role of the Study Director in the GLP program
• The history of adopting GLP guidance from pharmaceutical studies and how they transfer to medical devices

“GLP is front and center when submitting to global regulators.” – Sheri Krajewski

“GLP is for conducting non-clinical lab studies that support applications and submissions to regulatory bodies with the intent that these studies assure quality integrity of studies.” – Alison Shaffer

“We wear a lot of hats both externally with our customers and with the labs.” – Brandon Hahnlen

“We like to drive things. Not a lot of people know about this industry {and role of a Study Director} and a lot of us take a fortuitous route to get here.” – Theresa Ford-Wells

“One exciting thing is seeing the variety of medical devices. It’s neat to see over the years the trends and types of devices coming that we get to work on prior to anyone knowing they exist.” – William Adamiak

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Theresa Ford-Wells; Senior Study Director, NAMSA

Theresa Ford-Wells joined NAMSA in 2006, starting her career as an In Vivo Surgical Technologist before moving into a Study Director role in 2012. In 2017, she became a Senior Study Director, where she now manages many projects while helping to train other Study Directors. She also serves as a member of the NAMSA IACUC. Theresa holds a Bachelor’s Degree from Adrian College.

Brandon Hahnlen; Supervisor – Study Directors, NAMSA

Brandon Hahnlen joined NAMSA in 2010, supporting customers in a variety of laboratory and management roles including In Vivo Toxicology, In Vitro Biocompatibility and Analytical Services. Brandon holds a Bachelor’s Degree from the Kent State University, as well as an MBA from Bowling Green University.

Alison Shaffer; Senior Study Director, NAMSA

Alison Shaffer joined NAMSA in 2016, and focuses on oversight and direction of ISO 10993-18 Chemical Characterization studies, in addition to some of the more routine biocompatibility tests offered by NAMSA. Prior to NAMSA, Alison worked in the agrochemical and pharmaceutical industries in Indianapolis, gaining valuable lab experience in the fields of UPLC-MS and GC-MS instrumentation. Alison holds a Bachelor’s Degree and Master’s Degree from Trine University.

William Adamiak; Senior Study Director, NAMSA

William Adamiak has a background in Biomedical Engineering, which delves into various sciences and engineering disciplines. As a Study Director over the past five years, he has helped Sponsors conduct scientifically sound and clinically relevant studies. William also serves as the Primary Trainer within the Study Director Group at NAMSA’s Global Headquarters in Toledo, Ohio.

Sheri Krajewski; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.