Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 3: Maintaining Validation of Your Cloud Based Document Management Systems

Session Chair(s)

Karen  McCarthy Schau

Karen McCarthy Schau

Director, Risk-based Study Management

Vertex Pharmaceuticals, United States

Companies must use an effective and agile strategy to manage new releases in order to maximize the value of a cloud-based document management system. The session will be an interactive audience participation regarding the identification of the major pain points associated with maintaining a cloud-based system in a validated state as new releases and features are provided by the vendor. The panelists are industry experts on Regulatory, Clinical and Quality Document Management System who will describe the best practices their companies use to assess the impact of the new release. Topics of discussions will include: analysis, planning, configuration, customization, and testing. A major aspect of the new release is the impact of the changes on business operations.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify the challenges in maintaining a cloud-based document management system in a validated state regarding new releases and features
  • Define best practices for change control, validation, communication and training regarding new releases
  • Determine unique aspects of maintaining Regulatory, Clinical and Quality Document Management Systems

Speaker(s)

Michael  Agard, MS, RPh

Maintaining Validation of Your Cloud Based Document Management System

Michael Agard, MS, RPh

NNIT, United States

Director Clinical Consulting US

Jamie  Toth, MS

Maintaining Validation of Your Cloud Based Document Management Systems – eTMF from Business Perspective

Jamie Toth, MS

Beigene, United States

Global Head, TMF Management & Records

Jamie  O'Keefe

Managing Cloud Platforms Across Stakeholders - Platform vs Module Features

Jamie O'Keefe

Astrix, United States

Head, Clinical & Regulatory Consulting

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.