In this free webinar, gain insight into how regulatory bodies are transitioning validation guidelines to risk-based computer system assurance (CSA) and what this means for contract development and manufacturing organization (CDMO) operations. Attendees will learn practical approaches to consolidate validation management across enterprise resource planning (ERP), laboratory information management system (LIMS), enterprise systems and equipment qualifications. The featured speakers will discuss key metrics and key performance indicators (KPIs) to measure validation effectiveness and demonstrate compliance of systems to regulators. The speakers will also share real-world examples of how CDMOs have transformed their validation processes to accelerate time-to-market while maintaining compliance excellence.
TORONTO, May 28, 2025 /PRNewswire-PRWeb/ -- Today's contract development and manufacturing organizations (CDMOs) face unprecedented pressure from multiple fronts: evolving client demands, shifting regulatory landscapes and intense global competition.
As manufacturing contracts grow increasingly complex, traditional validation approaches are becoming unsustainable burdens on resources and timelines, creating bottlenecks that slow operations and increase audit risk exposure.
The life sciences industry stands at a critical juncture in system validation. As organizations navigate an unprecedented wave of technological change — characterized by cloud-based systems, frequent updates and extensive integration — traditional project-based validation methods are revealing significant limitations. These outdated approaches not only create operational bottlenecks but also accumulate "validation debt": the compounding cost of unaddressed burdens and future liabilities that threaten both compliance and innovation.
In this webinar, industry experts will explore how CDMOs can transform validation from a burden into a business differentiator. They will examine the shift from computer system validation (CSV) to computer system assurance (CSA), a risk-based paradigm that increases efficiency by replacing end-to-end "blanket" testing with risk-prioritized approaches.
The attendees will discover how leading organizations are leveraging modern validation technologies to reduce validation time by up to 80 percent while maintaining rigorous GxP compliance. The expert panel will address critical considerations for managing validation across multiple client products and systems with competing priorities, streamlining compliance processes to accelerate product delivery timelines and maintaining audit-readiness across increasing validation workloads. They will learn practical strategies for containing the total financial costs of system validation while ensuring regulatory compliance excellence.
Whether struggling with paper-based validation processes, fragmented approaches across systems or integration challenges with multiple platforms, this webinar will provide actionable insights to help organizations confidently navigate the evolving validation landscape.
Register for the webinar to discover how organizations can turn validation from a barrier into an enabler of innovation in today's rapidly evolving life sciences landscape.
Join William Gargano, Group Senior Vice President, Life Sciences/Data Solutions Division, RCM Technologies Inc.; Bryan Ennis, Chief Quality Officer and Co-Founder, Sware; and Bryan Holmes, Vice President, Information Technology, Andelyn Biosciences, for the live webinar on Tuesday, June 10, 2025, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Future-Proofing GxP: Strategic Investments and Validation Best Practices for CDMOs Amid Emerging Health Authority Regulations.
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