Anders Vidstrup

Anders Vidstrup

Company: NNIT

Job title: Senior IT Quality

Bio:

Anders Vidstrup is Senior IT Quality Subject Matter Expert at NNIT, with a background as mechanical engineer and have also a Diploma in Business Administration. He works with quality aspects of Computer Related Systems. He has been involved in requirement definition, design re-views, construction, quality assurance, commissioning and qualification activities. Over the last 13 years he has been involved in qualification of PCS systems in a large plants for drug-productions. He works with principles for qualification of cloud solutions and infrastructure and had in the time 2004-2009 the overall QA responsibility for the infrastructure in Novo Nordisk A/S include handling of security patches and qualify infrastructure components. Today he develops the Quality Management System in NNIT, and work as Quality Responsible on deliverables to both costumers in food and drugs industry as well as financial customers. In GAMP he is a part of the SIG group “Testing of GxP Critical Systems” and the group re-vising the Infrastructure SIG. For the new GAMP5 he gave a lot of input, e.g. the test appendix. Over years, he have been speaker at conferences under GAMP and other organizations.

Seminars:

Ask the experts: Midday Q&A + Open Counsel 12:30 pm

Let the speakers answer the questions from the audience in this open counsel.Read more

day: Day One

Interactive Panel Discussion: How Can Industry Shape the Standards for Cloud Solutions in GxP-Regulated Environments? 1:45 pm

How have international regulatory standards, and the subsequent interpretation of these guidelines helped or hindered the pharmaceutical industry through transitions onto cloud platforms? What should be the roles and responsibilities of cloud service users and cloud service providers? Which resources should life science companies refer to to maintain data compliance and remain inspection ready?Read more

day: Day One

Cloud Services – An Industry-led Framework for Adoption in the Regulated Life Sciences Industry 11:40 am

Introducing PhUSE – PhUSE is a global community of professionals passionate about the advancement of clinical information Exploring the key international requirements for GxP applications that meet regulatory needs Detailing the key issues with cloud adoption right now including data integrity, contract with cloud service provider and need to be inspection readyRead more

day: Day One

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