35th Annual SQA Takeaways: Emerging Trends in Quality, Compliance and More

Posted by Bill McGuckin on 5/15/19 9:42 AM

This year, the 35th Annual SQA Meeting and Quality College was home base for many of the Advanced Clinical Quality and Validation team members. With three of our teammates residing in the Atlanta area, we were quickly exposed to the cuisine, sights, and sounds of the city that hosted this integral meeting, with the theme, “Quality on My Mind,” which SQA President, Stephen Rogenthien, explained as “a play on words of the song Georgia on my Mind.”

As both exhibitors and attendees of many of the conference’s 70 presentations, the Advanced Clinical team certainly left with minds full of ideas for increased compliance, improved safety, and encouraging partnership opportunities.

The presentations covered a wide array of topics and were presented by subject matter experts from CROs, sponsors, consultants, and regulatory agencies. Those that attended were a highly engaged and diverse mix of tenured professionals, service providers, current students, and recent graduates searching for guidance, education, and partnerships as members of the quality community.

As a provider of GXP Quality Services, the Advanced Clinical Team was able to speak with multiple partners who recognize the value and need for auditing services. Many require a proven partner with full-time, salaried auditors to conduct audits on their behalf. As our team moved between educational sessions and the exhibits, many of these partners were able to meet their future Advanced Clinical auditor, right on sight.

When asked about her favorite session, Nikki Steiner, Senior Quality Auditor for Advanced Clinical, responded, “I really enjoyed Dean Z. Myers’ keynote speech during the Opening Plenary meeting. The 5 Universal Principles of Influence and Impact reminded me that quality is not about me, but about the safety and health of patients. It’s up to us to make the invisible visible, to be curious beyond curiosity, to check alignmen – and to remember that it is always about people."

Kyeana Knight, Senior Quality Auditor for Advanced Clinical, was asked the same question and said her favorite sessions included A Day in the Life of an Auditor in a Paperless Bioanlaytical Lab presented by Robyn Durr-Henry and The Evolving Role of Clinical Quality Assurance (CQA), presented by Celeste Gonzalez and Glenda Guest. 

Although the sessions were in different domains, Knight says both sessions focused on a common theme: the evolution of Quality Assurance professionals due to the changes in the industry.

“With the use of electronic lab books in the Bioanalytical arenas, and the implementation of risk-based thinking and data analytic applications in the clinical space, it really drove home the fact that, the essence of our job remains the same – ‘to assure processes are being followed and ensure data integrity and patient safety is maintained,’” Knight said. However, going forward, she claims must also become familiar and stay abreast on how to make these technological tools work and how to use them when doing our jobs, to ensure data integrity and patient safety are maintained and verifiable.”

One lasting impression from the meeting was the highly collaborative and seamless interaction between the regulatory monitoring authorities, conference attendees, and SQA representatives. While each attendee had a unique objective in mind, the overwhelming tone was to collaborate, promote and advance the ethics, principles, and knowledge of quality assurance in their respective fields. We are thankful for SQA as both an organization and gracious host and are fortunate to be part of such a thoughtful and altruistic quality community.

Last, but certainly not least, our team strongly recommends the Bison Burger at Ted’s Montana Grill and most of the tacos at Tin Lizzy’s Taco Tuesday!

           

See also: How to Successfully Build a Risk Based Monitoring Team

Written by:
Bill McGuckin
Senior Vice President, Consulting Services

Advanced Clinical
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Bill is responsible for the development, strategy, and delivery of Advanced Clinical’s Quality Consulting Services. He has held numerous leadership positions and has been recognized as a perennial top performer for his strategic thinking, cultivation of leaders, and innovative sales techniques.
Bill received his master’s degree from Monmouth University in Business Administration. Under his leadership, Bill’s teams have received many awards in recognition of their success in building record sales and profits.

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Tags: Quality, Technology