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