10 - 12 September, 2018 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands

Pre Conference Data Integrity Workshop Day

9:30 am - 10:00 am Welcome Coffee and Registration

10:00 am - 12:00 pm Best Practice in Maintaining Data Integrity

Rita Hadebe - Laboratory Manager, Lancet Laboratories
The collection, generation and maintenance of true data in the healthcare industry is patient centric. Using the role of a medical laboratory in provision of
accurate test results, we will review major processes in the lab and challenges in the collection of true data and the use of ISO standards, to address risks
and non conformances.

The Interactive Discussion will Examine the Following:

• Overview of generic principles of data integrity using ALCOA guidelines
• Generic strategies to maintain data integrity –how do we manage non compliance
• Creating a culture of quality, data verification and validation
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Rita Hadebe

Laboratory Manager
Lancet Laboratories

12:00 pm - 1:00 pm Networking Lunch Break

1:00 pm - 3:00 pm Designing Data Integrity into your Processes

Frans Boeijen - Manaing Partner, Ivalidate - IT
The way we collect data continues to evolve and is accompanied by the introduction of new technologies. The requirements we set for data
remain the same: to have confidence in the quality and integrity of the data, so that the underlying activities can be reconstructed. Can you rely on the quality and integrity of your (electronic) data? And how do you show that during an inspection? Organisations are not expected to use forensic techniques during routine checks. But it is expected that (automated) systems and processes are designed, documented and executed on a risk basis, so that an acceptable level of data integrity is achieved.

Attend This Workshop To:

• Explore your Data Life Cycle by Data Process Mapping
• Match the System Life Cycle
• Mitigate risks in the Data Life Cycle
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Frans Boeijen

Manaing Partner
Ivalidate - IT

3:00 pm - 3:30 pm Networking Coffee Break

3:30 pm - 5:30 pm Intepreting Data Integrity as an Organisational Immune System

Galit Lisaey - Data Integrity Consultant, GAL.IT
This workshop is designed to look at data driven decisions, how data could be produced, collected, analysed and stored. We will examine these specific
challenges through specific test cases, looking at data vulnerability, risk management and data integrity maintenance processes. This will allow you
to understand key criteria to achieve better systems and ensures you understand how your system can defend against system attack and invasion.

Attend this workshop to:

• Determine risk management as the backbone of
data integrity process implementation
• Understand the availability of data integrity tools to
establish strong quality management practices
• Discuss challenges that could be raised as part of
the process implementation and suggest solution
to resolve the limitations faced
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Galit Lisaey

Data Integrity Consultant
GAL.IT