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SQA 2023 Highlights – Day 1
Some interesting tidbits from the first day of the Society for Quality Assurance (SQA) Annual Meeting in National Harbor, Maryland:
In the plenary session, Chrissy Cochran, Director of the Bioresearch Monitoring Organization, US FDA, reviewed key points of the FDA Omnibus Reform Act of 2022 that affect inspections. FDORA, as it is known, makes the FDA’s authority to conduct inspections more explicit and added authority to conduct inspections for public health reasons. The act clarifies that inspectees can include sponsors, contractors, subcontractors, and related business facilities. It also gives FDA the authority to request records to support or in lieu of an on-site inspection (compliance with these requests was previously voluntary). FDA is required to develop guidance for industry on records requests as well as additional BIMO inspection guidance, so look for those drafts within the next year and a half.
Robin C. Guy, MS, DABT, RQAP-GLP presented a poster with the results of SQA’s Quality Assurance Consulting Service (QACS) Salary and Business Practice Survey. Mean income for QA consultants surveyed was $205k, with no statistical difference in annual income between consultants with certifications and those without.
Niall Ferguson and Linda Hook-D’Innocenzo led a discussion on implementing a quality culture. Participants emphasized the need to get senior management buy-in and the importance of understanding business drivers, including costs and efficiency.
Valgenics presented a poster showcasing a case study of validation using the Computer Software Assurance paradigm, per FDA’s new draft guidance. The upshot: CSA appears to be risk-based validation that is truly risk-based; the validation team was enthusiastic about the approach because it was lighter on documentation; and Valgenics concluded that best validation practices should consume only 5% of a project’s resources, a metric greatly aided by automated testing.
In a GLP panel discussion, Richard Crossland and Cassandra Kennedy of LabCorp joined Dr. Cochran and Eric Pittman of FDA discussed the “Future of QA,” including remote work and machine learning. The long-awaited update to the GLP, targeted for initial release by the end of 2023, will be more of a “tweak” than a rewrite, the panelists hinted, reminding the audience that the GLP’s purpose is to “ensure quality, not perfection.”
Computer System Guidance: Digital Health Technologies