Quality Excellence in 2026: Navigating Critical Trends in Pharma and Medical Device Quality Management

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Key Takeaways

  • The Five Critical Trends reshaping quality management across pharma and medical devices—and why 2026 marks the point of no return
  • How to Govern AI Effectively while capturing 20-30% ROI and satisfying AI-empowered inspectors armed with pattern-detection tools
  • The CSV-to-CSA Transformation Blueprint for implementing risk-based validation that reduces validation time to under 45 minutes while strengthening compliance
  • Perpetual Digital Readiness Strategies to thrive in the "inspection-anytime" reality of permanent remote regulatory assessments
  • Industry-Specific Imperatives including DSCSA compliance, the February 2, 2026 QMSR go-live, and supply chain transparency
  • How MasterControl's Quality Excellence Platform** and AI tools specifically address each 2026 trend with proven results

About This Event

The rules of quality management are being rewritten—and 2026 is the deadline. With FDA warning letters up 41% and multiple critical regulations going into full enforcement, quality leaders in both pharmaceutical and medical device industries face a pivotal moment: evolve your quality systems now, or risk falling behind in an inspection-anytime reality.

This essential webinar cuts through the complexity to reveal critical trends reshaping quality management across life sciences, including:

  • Discover why artificial intelligence has moved from experimentation to regulatory expectation, delivering 20-30% ROI while demanding new governance frameworks.

  • Learn how the FDA's finalized Computer Software Assurance (CSA) guidance is transforming validation from documentation exercises into risk-based strategic decisions.

  • Understand why remote regulatory assessments have become a permanent FDA oversight tool, creating an "always-on" inspection environment that demands perpetual digital readiness.

But here's what makes 2026 unique: these challenges present unprecedented opportunities for organizations with the right quality infrastructure. Whether you're navigating the Drug Supply Chain Security Act (DSCSA) in pharma, preparing for the February 2, 2026 QMSR go-live in medical devices, or managing software bills of materials (SBOMs) for connected devices, you're facing converging trends that share common solutions.

Whether you're managing product quality across multiple sites, preparing for your next inspection, or building the business case for quality system modernization, this webinar provides the strategic framework and tactical guidance you need to succeed in the new quality landscape.

Key Takeaways

  • The Five Critical Trends reshaping quality management across pharma and medical devices—and why 2026 marks the point of no return
  • How to Govern AI Effectively while capturing 20-30% ROI and satisfying AI-empowered inspectors armed with pattern-detection tools
  • The CSV-to-CSA Transformation Blueprint for implementing risk-based validation that reduces validation time to under 45 minutes while strengthening compliance
  • Perpetual Digital Readiness Strategies to thrive in the "inspection-anytime" reality of permanent remote regulatory assessments
  • Industry-Specific Imperatives including DSCSA compliance, the February 2, 2026 QMSR go-live, and supply chain transparency
  • How MasterControl's Quality Excellence Platform** and AI tools specifically address each 2026 trend with proven results

Jessica Madsen

Senior Product Marketing Manager

MasterControl

Manufacturing, Quality, and Asset Management — Simplified with Life Sciences-Specialized AI.

Jessica is the Sr. Product Marketing Manager over MasterControl Quality Excellence. She has an extensive marketing career spanning nearly 20 years including leadership, strategy, product marketing, customer marketing, and demand gen. Jessica excels at working across teams to bring products to market and translating tech features to customer benefits that resonate.

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