Keeping the tip of the GLP spear sharp: SQA 2016

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T3 Labs leads with Quality – T3 Labs is an agile, responsive trusted partner – every time to everyone. The team at T3 Labs takes great pride in our GLP program for preclinical testing. We have archived more than 50 GLP studies for our sponsors from which more than 30 medical devices and products have cleared the regulatory approval process.  

However the world of medtech innovation is always in flux. Innovation, policy and regulatory changes breed a constant flow of new regulatory guidelines of which we must remain aware and in which we must remain proficient in order to best serve our sponsors. Moreover, the standard operating procedures and policies that drive our GLP efforts dictate our non-GLP work including physician training and our business practices. Therefore, how we implement our approach to GLP drives the rest of T3 Labs’ operational mindset.

The Society for Quality Assurance (SQA) is one of the medtech industry’s leading organization committed to promoting quality in the regulatory medical research industry. For eight of the past 10 years, T3 Labs Director of Preclinical Quality Assurance Ken Zielmanski has participated in the SQA annual conference. He will do so again this year at the 32nd SQA Annual Meeting and Quality College, “Cultivating a culture of quality.” Here’s why.

Always remaining “audit-ready”

Representatives from the US FDA, CDRH and other regulatory bodies give seminars and lectures on the latest in compliance at SQA including issues they have found visiting other CROs. This supports our vigilance that ensures our areas of operation remain steadfastly in line with what regulators require from CROs participating on the leading edge of medtech innovation with our sponsor partners.

New FDA updates, requirements

Medical product innovators and the organizations that serve them are eagerly awaiting the pending approval on a revision of the FDA Code of Federal Regulations, 21CFR part 58, that governs GLP for conducting nonclinical laboratory studies. Anytime FDA representatives share new knowledge or audit findings we are able to better understand what the gatekeepers of our sponsors’ advancement need.

Camaraderie and peer learning opportunities

QA professionals from other CROs with decades of experience now have their own consultancies. Reconnecting with them at SQA frequently generates new GLP process improvements including implementation and issue resolution. Many of these colleagues perform internal audits that mimic those performed by the FDA ensuring we are always ready.

What we are most looking forward to

FDA submission requirements change at a pace that relates directly to the speed  and complexity of medtech innovation. Therefore we are interested in staying ahead of the prevailing requirements thru conscious participation at SQA.  Topics we are most interested in involve FDA  updates on GLP-related topics, presentations on compliance and validation of information systems.  We will attend and follow these closely.

For any of our colleagues who have not had formal GLP training regardless of their tenure in the field, the SQA Quality College is a high value affair. How to build protocols, critical reporting requirements, documentation, archiving and retention have proven highly valuable to T3 team members. The college addresses not only the “how,” but the “why” GLP requirements are critical to the safety and efficacy of the new devices and products intended to improve healthcare.

At the end of the day, GLP and the SQA is all about the safety of  the product development pathway to patients. We write and execute the preclinical testing approval protocols for devices and products that will eventually improve healthcare. Ensuring we remain on the forefront of the latest FDA requirements and take every opportunity to learn from the experience of our peers is all the reason we need to invest in the SQA Conference every year.

Connect with Ken Zielmanski at SQA 2016 by emailing kenneth.zielmanski@emoryhealthcare.org

If you are evaluating your medical product’s readiness for preclinical testing or training contact info@t3labs.org or call 404-251-0600.