Key Takeaways from the 2026 SQA Annual Meeting

The Society of Quality Assurance held its 2026 Annual Meeting in National Harbor, Maryland, 13–15 April. With sessions spanning GLP, GCP, GMP, medical devices, IT compliance, and professional development, the program reflected an industry navigating rapid change on multiple fronts. Here are the themes that stood out.

1. FDA Is Modernizing — and Practicing What It Preaches

The FDA’s presence at this year’s meeting went well beyond the usual regulatory updates. Across the opening and morning plenaries, Tuesday’s BIMO sessions, and the closing regulatory Q&A, a consistent picture emerged: the agency is not just setting expectations for industry, it is actively retooling its own operations.

OBMI restructuring. The Office of Bioresearch Monitoring has undergone an organizational restructuring aimed at streamlining processes and improving efficiency. Notably, OBMI disclosed that it is now using an internally developed AI system called ELSA to support administrative tasks and documentation review, a striking example of the agency adopting the same technologies it expects industry to govern responsibly.

The CNPV pilot program. The Commissioner’s National Priority Voucher program, launched in June 2025, aims to compress standard drug review timelines from 10–12 months to just 1–2 months for products meeting specific eligibility criteria aligned with critical national health priorities. As of the meeting, 18 vouchers had been awarded and four approvals granted, including two oncology approvals delivered within 44 and 55 days of filing. The program uses a multidisciplinary review model with enhanced sponsor–FDA communication throughout the process.

Unified adverse event monitoring. The FDA announced a new consolidated Adverse Event Monitoring System that replaces the scattered legacy databases — FAERS, VAERS, AERS, MAUDE, HFCS, and CTPAE — with a single platform. For quality and pharmacovigilance teams long accustomed to navigating multiple fragmented systems, this is a welcome development.

Electronic records and FDORA. On the inspection front, the FDORA Act requirements around electronic records access generated practical discussion. Companies are now expected to provide investigators with read-only access to electronic systems and determine the best approach for sharing electronic records for FDA’s internal files. The agency acknowledged that better solutions are still in development, but offered existing options including USB drives, Box.com, Microsoft Teams, and printed copies. For organizations that have not yet planned how they would facilitate electronic record sharing during an inspection, the time to prepare is now.

2. AI Governance: Treat It Like Any Other GxP System

If last year’s meeting introduced AI as a topic of curiosity, this year’s program made clear that the conversation has shifted decisively toward governance, validation, and responsible deployment. AI was featured in sessions across every discipline track — from establishing GxP governance frameworks and applying Computer Software Assurance principles, to practical roundtables on how QA teams should respond when their organizations adopt AI tools without waiting for quality input.

The overarching message was unambiguous: AI tools in regulated environments require the same rigor as any other GxP software. They are not subject to less scrutiny or documentation simply because they are new. Multiple sessions converged on a practical framework built around four areas:

• Governance and Risk — Organizations need formal AI Use Policies, criticality assessments to determine the risk profile of each use case, and a clearly documented scope of use.
• Validation and Assurance — Validation should be right-sized to the risk, following CSA-based thinking, but it must exist. Enterprise versions of AI software should be preferred over consumer tools wherever possible, as they offer greater control over configuration, data handling, and audit trails.
• Vendor and Supplier Oversight — AI vendors and suppliers require assessment and ongoing oversight just like any other GxP service provider. Understanding what the tool does with your data, where models are hosted, and how updates are deployed is essential.
• Human-in-the-Loop and Accountability — This was perhaps the most emphasized theme across all AI sessions. The expectation is not simply that a person is available to review AI outputs, but that processes are designed with human oversight built into every decision point. Responsibility must remain with the human using the system — not be transferred, implicitly or explicitly, to AI itself. Organizations also need to monitor for model drift over time and ensure transparency and explainability of AI outputs.

That last point, keeping the human central, connects to a broader theme that ran through the non-AI sessions as well. Multiple presentations explored leadership, critical thinking, professional development, and what one session called “the human architecture of quality.” From storytelling as a leadership skill to designing systems that reduce human error, the program acknowledged that no framework, tool, or AI system works without skilled, empowered people behind it. In a year when so much of the conversation focused on technology, the emphasis on investing in people felt both timely and necessary.

3. New Approach Methodologies: The Nonclinical Landscape Is Shifting

There was palpable industry interest in New Approach Methodologies (NAMs) at this year’s meeting, and with good reason. On March 18, 2026, just weeks before the conference, the FDA’s Center for Drug Evaluation and Research published a draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development, for comments. The guidance provides a validation framework for non-animal testing methods, including complex in vitro models, organ-on-chip systems, in chemico studies, and in silico approaches, and signals FDA’s intent to move toward more human-relevant nonclinical data.

For organizations with GLP testing programs or nonclinical study oversight responsibilities, this is a space to watch closely. The draft guidance does not prescribe specific NAMs but establishes the scientific principles against which any NAM submission will be evaluated, making early engagement with the comment period particularly valuable.

4. Across the Program: GCP in the Spotlight

With the recent updates to ICH E6, the GCP track deserves mention for the sheer volume and depth of its programming. Sessions spanned the full lifecycle of clinical quality oversight: ICH E6(R3) implementation and what it means in practice, Trial Master File management, including the introduction of the CDISC TMF Standard Model as a move toward greater standardization, and the advancement of Risk-Based Quality Management through AI-enabled digital platforms. Pharmacovigilance inspection readiness across MHRA, EMA, and FDA jurisdictions featured prominently, as did a 90-minute roundtable on redefining GCP inspection readiness drawing on lessons learned from joint FDA/SQA workshops.

Beyond GCP, the breadth of the program was a reminder that the SQA community increasingly operates across multiple regulatory frameworks simultaneously — GLP, GCP, GMP, medical devices, and EPA requirements — each with distinct and sometimes conflicting obligations.

5. Quality Management Maturity: From Compliance to Quality by Design

For anyone who attended last year’s RQA annual conference, the Quality Management Maturity theme at SQA 2026 will feel like a natural continuation of the Quality by Design conversation. Where QbD asks organizations to build quality into processes from the outset rather than inspecting it afterward, the maturity concept pushes that thinking further, asking not just whether your processes are well-designed, but whether your quality system as a whole is proactive, risk-aware, and capable of driving continuous improvement.

Sessions covered FDA’s Quality Management Maturity (QMM) framework applied to clinical trials, stakeholder mapping and partnership, data-driven risk monitoring, and the perennial challenge of making CAPA genuinely preventive rather than just a mechanism for closing deviations. The thread connecting these sessions was a push toward systems-level quality thinking. Compliance remains the floor, but maturity, the ability to anticipate, adapt, and improve, is increasingly the expectation.

6. Electronic Archiving: Preservation Is Harder Than It Looks

The Scientific Archiving panel brought into focus a set of challenges that are easy to underestimate until you are facing them. As more records exist only in electronic form, organizations must ensure the long-term readability of legacy file formats, protect archived data against cybersecurity threats — ransomware being the most prominent concern — and conduct proper due diligence when hosting archived data in the cloud. These are not theoretical risks: format obsolescence, data loss from cyberattacks, and unclear cloud provider responsibilities are all scenarios that have materialized across the industry.

For anyone responsible for record retention and retrieval, this session was a reminder that archiving is not simply storage — it is an active, ongoing quality and IT challenge.

Looking Ahead

The closing keynote from former FDA Commissioner Robert Califf on evolving regulatory expectations provided a fitting capstone to a meeting that was, in many ways, about the pace of change itself. Whether the topic was AI governance, inspection modernization, or quality culture, the underlying question was the same: how do quality professionals stay ahead of change rather than reacting to it?

April 16, 2026
Contributed by: Kate Peters, Director Quality Assurance