4th Annual GxP Cloud Compliance Summit

Join USDM in Boston, MA | September 5-7, 2023

Join USDM and more than 100 life science quality and IT professionals at the GxP Cloud Compliance Summit. We will discuss developing and implementing a practical roadmap to migrate your GxP-regulated applications to the cloud with real-life insights from regulatory, security, and quality experts from leading life science companies, cloud providers, auditors, and industry regulators.

Presenters will share real-life case studies covering successes and failures during this in-depth knowledge-sharing event. Discussion topics include:

  • Navigating the shift from Computer System Validation (CSV) to Computer Software Assurance (CSA)
  • Continuing to develop relationships with vendors by establishing the responsibilities that each party is accountable for
  • Understanding how to find the least burdensome approach to satisfy regulatory requirements, saving you time and money
  • Using test automation strategies to safeguard and speed up GxP compliance
  • Guaranteeing data is encrypted, secure, and has a low risk of being manipulated

For a limited time, friends of USDM can use our discount code of GxPSPON20 to save 20% on your registration fee. Register here.

 

USDM will be leading two sessions that we hope you will join.

Wednesday, Sept 6 | 9:30 am | GxP Process Automation & Continuous Cloud Compliance

Many critical regulated life sciences processes aren’t supported by traditional GxP applications and are managed in spreadsheets and email. With ProcessX, you can automate any manual GxP process, delivering up to 5x speed and efficiency.

Learn how to:

  • Manage GxP and Non-GxP workflows on the ServiceNow Platform
  • Solve for 21 CFR Part 11 eSignatures and audit trails
  • Automate and scale your business processes while maintaining compliance
  • Utilize out-of-the-box solutions for Regulated IT Workflows, GMP Manufacturing Workflows, Adverse Event Workflows, and more.

 Presenters

Wednesday, Sept 6 | 4:00 pm | Leveraging Vendors to Simplify Validation

The panel will discuss:

  • CSA promotes leveraging vendor activities; it starts with selecting the right vendor
  • Customer vs. vendor responsibilities for achieving and maintaining compliance
  • Considerations for release management to ensure continuous compliance
  • Guidance to improve your cloud compliance and automation maturity

 Panelists:

  • David Blewitt, VP of Cloud Compliance, USDM Life Sciences
  • Evjatar Cohen, Global Head of Life Sciences, ServiceNow
  • Manu Vohra, Managing Director, Global Life Sciences, Box
  • Lisa Om (moderator), VP of Marketing, USDM Life Sciences

We look forward to connecting with you in Boston!

Use our discount code for 20% off –> GxPSPON20

 

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