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 These outdated approaches not only create operational bottlenecks but also accumulate “validation debt”: the compounding cost of unaddressed burdens and future liabilities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.
Join this webinar to discover how organizations can turn validation from a barrier into an enabler of innovation in today’s rapidly evolving life sciences landscape.
Speakers
William Gargano, Group Senior Vice President, Life Sciences / Data, Solutions Division RCM Technologies Inc.
William Gargano oversees the Life Sciences / Data Solutions Division of RCM Technologies, Inc., a publicly traded IT, Engineering and Healthcare Services firm established in 1971. As Group Senior Vice President, he is responsible for driving divisional strategy and ensuring operational excellence.
Mr. Gargano brings over 35 years of experience in the life sciences industry, with deep expertise in regulatory and compliance issues, gained through extensive collaboration with the FDA and other global regulatory agencies. He advises clients on regulatory compliance, data management and IT strategy, offering guidance rooted in decades of firsthand experience. His professional career includes executive leadership roles at CGI, Taratec Development (acquired by Capgemini), DMR, Pharma-Bio Serv and KPMG.
His career has spanned continents, living and working with clients throughout Europe, Asia and South America, providing him with valuable international insight and expertise. Outside of work, Bill enjoys woodworking, jazz music, traveling and diving in the world of science fiction.
Message Presenter
Bryan Ennis, Chief Quality Officer and Co-Founder, Sware
Bryan Ennis is currently the Chief Quality Officer and Co-Founder of Sware.
Sware is a validation solution provider dedicated to rescuing life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP and business requirements. Previously, he ran Global Regulated Systems at Genzyme before joining Veeva, where he was on the founding team of the widely used Veeva Vault platform. He spent six years at Veeva running the R&D Customer Success Department. He has worked with over 150 life sciences companies to develop validation and IT quality strategy.
Message Presenter
Bryan Holmes, Vice President, Information Technology, Andelyn Biosciences
Bryan Holmes is a seasoned IT leader with over two decades of experience in the pharma and biotech sectors. Currently serving as the Vice President of Digital & Technology Solutions at Andelyn Biosciences, Bryan is at the forefront of driving the Digital CDMO Vision—leveraging data, security and user experience to deliver competitive advantages.
With a strong background in GxP systems and IT operations, Bryan has held pivotal roles at Merck, Boehringer Ingelheim and Hikma, both in-house and as a consultant. His expertise spans across a range of technology solutions, positioning him as a key architect of digital transformation in the life sciences industry.
Message PresenterWho Should Attend?
This webinar is intended for IT and Quality professionals who are responsible for managing organizations technology, including optimizing investments, identifying risk and being audit-ready:
- Head of IT
- Director of IT
- Chief Information Officer
- Head of Quality
- Director of Quality
What You Will Learn
Attendees will learn about:
- How regulatory bodies are transitioning validation guidelines to risk-based CSA and what this means for CDMO operations
- Practical approaches to consolidate validation management across ERP, LIMS, enterprise systems and equipment qualifications
- Key metrics and key performance indicators (KPIs) to measure validation effectiveness and demonstrate compliance of systems to regulators
- Real-world examples of how CDMOs have transformed their validation processes to accelerate time-to-market while maintaining compliance excellence
Xtalks Partner
Sware
Sware’s mission is to rescue life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. The Res_Q™ software platform offers the most complete validation solution available today. Res_Q eliminates validation debt and ensures peace of mind in an increasingly complex technology ecosystem. For more information, visit www.sware.com.
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