Join us in London, UK on the 3. October 2018

Practical Solutions in CSV and SDLC for GXP & MedDev

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) or others (Redmine, TFS, etc.).

If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or development of 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), data integrity and the validation of software and applications, like ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012.

Read here the recap article of the first event from February 2018!

This conference covers regulations, standards, case studies, examples and solutions!

  • Regulations and Standards – GXP & SDLC vs. GAMP 5 and Data Integrity (Mr. Markus Roemer, Ambassador ISPE DACH)
  • Using JIRA and Confluence as eQMS (Mrs. Rina Nir, Atlassian Solution Partner)
  • GXP development approach, cloud solutions and deployment (Mr. Keith Williams, Member of ISPE GAMP European Committee)
  • Using CMMI and Scrum: SW development for GMP products and supplier audits – a practicable example (Mr. Stellan Ott)
  • 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) – LIVE DEMO

How to register?

Open the following link: REGISTER

The official conference language will be English.

Confirmed 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); and others

Read more about this topic online.