Practical Solutions in CSV and SDLC for GXP & MedDev
03.10.2018

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.
Agenda
Stellan Ott (CEO at Wolfram Ott & Partner GmbH)
Markus Roemer (Chief consultant and founder of Comes Compliance Services, Ambassador ISPE DACH)
Keith Williams (Former member of ISPE GAMP European Committee, Principal Consultant, C3 Limited)
Rina Nir (CEO at RadBee Ltd.)
Laurence Sampson (Sr Director Medical & Lifescience, Industry Strategy, Siemens Product Lifecycle Management Software Inc.)
Carl Pullen (Senior Consultant Mechanical Engineer – Technical Project leader, Cambridge Design Partnership)
Klavs Esbjerg (CEO and Founder, Epista Life Science)
Register
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