How to validate computerised systems used for GxP and Medical devices environments. Computers system validation in an Agile age

Posted on Posted in General

8 February 2018, Stuttgart, Germany (9:00-17:00m)

Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany

In an age where computerised systems make the difference between winning and loosing, we need to find ways to continuously and relentlessly innovate our systems.  Today, compliance is no longer enough: we need a validation framework which helps the business move quicker and release often.

In this one day conference we will explore the newest trends in computers system validation (CSV). Experts will share perspectives on standards and guidelines for setting up a CSV framework, as well as on available technologies and tools which can reduce the burden of CSV.

The talks will focus on CSV in GXP (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) environments, when compliance with regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11 is mandatory.

Programme

  • 09:00-09:30 Registration and coffee
  • 09:30-09:45 Introduction
  • 09:45-10:45 Regulations and Standards – GXP & SDLC vs. GAMP 5
    • Mr. Markus Roemer, Ambassador ISPE DACH
  • 10:45-11:45 Using JIRA and Confluence as eQMS
    • Mrs. Rina Nir, CEO of RadBee, An Atlassian solution partner
  • 11:34-12:00 Coffee break
  • 12:00-12:45 Using CMMI and Scrum: SW development for GMP products and supplier audits
    •  Mr. Stellan Ott, CEO at Wolfram Ott & Partner GmbH
  • 12:45-13:30 Lunch
  • 13:30-14:30 GXP cloud solutions and software deployment
    • Mr. Keith Williams, Member of ISPE GAMP European Committee
  • 14:30-15:30 Using Confluence as eValidation Tool – example for a GAMP category 5 application for GVP
    • Mr. Markus Roemer, Ambassador ISPE DACH
  • 15:30-15:45 Coffee break
  • 15:45-16:30 Making JIRA and Confluence GXP-ready
    • Mrs. Rina Nir, CEO of RadBee, An Atlassian solution partner
  • 16:30-17:00 Experts panel and closure

Join the conference

How to validate software development tools used for GXP and MedDev?