Process over Projects: Rethinking GxP System Validation in an Age of Rapid Change

Life Sciences, Pharmaceutical Regulation, Pharmaceutical,
  • Thursday, November 14, 2024 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

In today’s rapidly evolving life sciences landscape, treating validation as a series of isolated projects is no longer optimal. This webinar discusses the critical importance of treating validation as a core element of an organization’s quality management system (QMS). Integration into the QMS promotes active management of validation activities and deliverables, allowing for the development of metrics for measuring key process indicators (KPI).

In this webinar, the speakers will explore ways to efficiently position validation within quality management, as well as how organizations can gain better control over validation planning and execution, eliminating runaway and siloed validation projects. Attendees will get to discover how to harmonize validation processes with existing quality management processes and use key performance indicators to measure and improve validation effectiveness. They will also discuss the impact of artificial intelligence (AI) on validation and the anticipated increased regulatory scrutiny in this area.

Join this webinar to gain insights into how integrating validation and GxP compliance in quality management systems will improve cross-functional collaboration and futureproof regulatory adherence in an increasingly complex technological landscape.

Speaker

Bryan Ennis, Sware

Bryan Ennis, Chief Quality Officer & Co-Founder, Sware

Bryan Ennis is the Chief Quality Officer and Co-Founder of Sware, 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 nine 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

Who Should Attend?

This webinar is intended for IT and Quality professionals who are responsible for managing organizations technology, including optimizing investments, identifying risk, spear-heading software validation and being audit-ready and those having the following job titles:

  • Head/Director of IT
  • Chief Information Officer
  • Head/Director of Quality
  • Director of Validation Services
  • Project Managers (IT/Validation/Quality)

What You Will Learn

Attendees will learn about:

  • How can treating validation as a core part of your QMS rather than a series of projects improve an organization’s ability to manage risk and maintain compliance
  • Metrics and KPIs to measure the effectiveness of the validation processes and drive continuous improvement
  • How the integration of AI in life sciences will impact validation practices

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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