Practical Solutions in CSV and SDLC for GXP & MedDev


In an age when computerised systems are dividing lines between winning and losing, you need to find ways to continuously and relentlessly innovate. Compliance is no longer enough; you need a validation framework to help your business move quicker and release more often. At the conference, industry experts will explore the newest trends in computer system validation (CSV), share insights on standards and guidelines for setting up a CSV framework, and relate their experiences with the best available technologies and tools to effectively reduce the burden of CSV.

You'll have the opportunity to participate in presentations focused on CSV in GXP (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) environments, where compliance regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11 are mandatory. By the end of the conference, you'll have a full arsenal of practical knowledge and invaluable insight that adds value to your quality management system and organisation overall.


The Capability Maturity Model Integration (CMMI) and a framework for agile software (Scrum) for GMP products and supplier audits
Stellan Ott (CEO at Wolfram Ott & Partner GmbH)
Using Jira and Confluence as e-QMS
Rina Nir (CEO at RadBee Ltd.)
Computer System Validation (CSV) for Jira and Confluence: a sensible and compliant approach
Markus Roemer (Chief consultant and founder of Comes Compliance Services, Ambassador ISPE DACH)
Data Integrity: a practical perspective
Keith Williams (Former member of ISPE GAMP European Committee, Principal Consultant, C3 Limited)
Software Development Life Cycle (SDLC) management: marrying DevOps principles with a compliant software release
Rina Nir (CEO at RadBee Ltd.)
Regulatory landscape updates and the urgency of digitalization
Laurence Sampson (Sr Director Medical & Lifescience, Industry Strategy, Siemens Product Lifecycle Management Software Inc.)
Use case demo: Requirements management concepts and how Polarion is used to drive a more effective development approach
Carl Pullen (Senior Consultant Mechanical Engineer – Technical Project leader, Cambridge Design Partnership)
Proactive quality risk management
Klavs Esbjerg (CEO and Founder, Epista Life Science)


Join us on the 3.10.2018 in London, UK
Practical Solutions in CSV and SDLC for GXP & MedDev


Ort: London / Royal College of General Practitioners / 30 Euston Square