How to validate Software Development tools used for GXP and MedDev?

8 February 2018, Stuttgart, Germany (9 am to 5 pm)

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

The programme will focus on regulated companies that are in the process of the implementation and validation of software development tools like JIRA, BitBucket and Confluence (Atlassian). If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) these must comply with regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11.

Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012.

This conference covers regulations, standards, examples and solutions!

  • Regulations and Standards – GXP & SDLC vs. GAMP 5 (Mr. Markus Roemer, Ambassador ISPE DACH)
  • Using JIRA and Confluence as eQMS (Mrs. Rina Nir, Atlassian Solution Partner)
  • Using CMMI and Scrum: SW development for GMP products and supplier audits (Mr. Stellan Ott)
  • GXP cloud solutions and software deployment (Mr. Keith Williams, Member of ISPE GAMP European Committee)
  • Using Confluence as eValidation Tool – example for a GAMP category 5 application for GVP  (Mr. Markus Roemer)
  • Making JIRA and Confluence GXP-ready (Mrs. Rina Nir)

Early Bird Rate until 24. December 2017: 399,00 €

How to register?

Just fill out the form below and register online today:


The official conference language will be English.

Speakers: Mrs. Rina Nir (RadBee Ltd, UK); Mr. Stellan Ott (ott+partner GmbH, Germany); Mr. Keith Williams (C3 Management Limited, UK); Mr. Markus Roemer (CCS, Germany);

General terms and conditions

If you cannot attend the conference you can send a colleague or if you have to cancel entirely we must charge the following fees: Cancellation until 2 weeks prior to the conference 20 %, within 2 week prior to the conference 80 %.

By registering for this conference, you accept the processing of your data. You will get an invoice based on your binding registration. By paying the invoice you will be officially registered to the conference as participant in writing.

Terms of payment: Invoice payable within 15 days after receipt of invoice. Costs and prices are net without VAT.

We may change the content or speakers without notice or we must cancel the conference. If the conference must be cancelled, you will be notified as quick as possible and you will receive a full refund of all paid fees.

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