The QB1 of GLP

BiocompCHATibility vor 4 Jahren

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41:31

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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