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.

Speakers

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
Aryaz Zomorodi, SpringWorks Therapeutics

Aryaz Zomorodi, Systems Quality Associate Director, SpringWorks Therapeutics

Aryaz Zomorodi is the Associate Director of Systems Quality at SpringWorks Therapeutics, a leading biotechnology firm specializing in oncology, rare diseases and targeted therapies. With over 15 years of expertise in quality management, Aryaz has most recently held key positions at Arena Pharmaceuticals and Pfizer following Arena’s acquisition. Driven by a passion for leveraging artificial intelligence to foster innovation and enhance efficiency, Aryaz is currently pursuing a graduate degree in Applied Artificial Intelligence. He is also a Certified Quality Auditor and holds a Black Belt in Lean and Six Sigma, demonstrating his commitment to excellence and continuous improvement.

Message Presenter
Jennifer Chang, Blue Mountain

Jennifer Chang, Quality Assurance Intelligence Specialist, Blue Mountain

Jennifer Chang is a seasoned quality professional with a diverse array of experiences in food and pharmaceutical manufacturing, bringing specialized yet grounded expertise in quality systems, regulatory compliance, electronic systems, and risk management. Through her role as QA Intelligence Specialist, Jennifer leverages hard-earned industry knowledge to promote ongoing compliance and continuous improvement at Blue Mountain. Jennifer employs a practical approach to decrypt intricate regulatory requirements and assist customers in navigating a complex and evolving compliance landscape.

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, including those with 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 gain insights into:

  • How treating validation as a core part of a QMS rather than a series of projects can 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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