Shane De Büchel, the Senior Manager of Quality Assurance Compliance and Systems at KCAS, recently attended the 39th annual SQA Conference in National Harbor, Maryland. This conference was hosted by the Society of Quality Assurance, an organization of quality assurance professionals from all over the world, primarily the U.S., Europe, and Canada. The conference had an international audience of regulatory professionals, including the director of the Office of Bioresearch Monitoring Operations, ORA, FDA, Dr. Chrissy Cochran, and her regional directors with Eric Pittman and Annette Johnson, as well as leaders from Canada’s Health Organization, MHRA, out of the United Kingdom, and many others.
Key Messages From SQA this Year
Despite being the first, solely, in-person event since the pandemic, the conference still had around 780 attendees. One of the significant takeaways from the conference was cloud computing, an up-and-coming technology that many different sectors are starting to adopt. However, the industry is looking for guidance from regulatory agencies regarding this technology. OECD is preparing to publish a paper that provides clarification on the existing information. The FDA, on the other hand, is not publishing a paper but relying on the already existing guidance. Companies will have to determine which approach is best suited to their needs.
Shane also presented regulatory updates to the senior leadership team at KCAS’s Olathe site, as well as the France and Springhouse locations. Shane had participated in creating a data integrity book with the Society of Quality Assurance, which is yet to be published, and revealed that a paid membership in the society is open to any quality assurance professional with the applicable years of experience. The Midwest Society of Quality Assurance (MWSQA) is a regional group that serves as an introduction point for smaller companies that may not have the funds to join the larger society. The MWSQA annual meeting is late July in Kalamazoo, MI.
The digital and cloud computing aspect of the conference was a significant topic of discussion. Companies are still hesitant to adopt cloud computing because they prefer on-premises solutions where they can control everything. However, cloud computing is the way of the future, and companies will need to adapt to keep up with technological advancements. Position papers from regulators will help with this transition, as companies will need to share responsibilities of what the regulations require between themselves, their provider, and the host. Companies that are unwilling to make the shift risk falling behind as technology progresses.
Overall, the conference provided a diverse array of speakers on emerging and consistent issues within the industry. The international audience made for a unique experience, and the guidance on cloud computing will be helpful to companies looking to adopt this technology. Shane found the conference beneficial to attend because they could bring back the regulatory updates and information on cloud computing that would help KCAS stay up-to-date with industry trends and needs, allowing them to apply and adjust their processes accordingly.