16 - 18 September, 2019 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands
Dora Endreffy, Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records Manager at ICON

Dora Endreffy


Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records Manager
ICON

Check out the incredible speaker line-up to see who will be joining Dora.

Download The Latest Agenda

Pre Conference Data Integrity Workshop Day

Saturday, November 10th, 2018


10:00 AM DATA INTEGRITY AND COMPLIANCE TRAINING DAY - ENSURING LABORATORY EXCELLENCE: DATA INTEGRITY EXPECTATIONS, CHALLENGES AND BEST PRACTICES FOR GLP COMPLIANCE

Introduction:
Inspections can occur at anytime; therefore, the preparation can be daunting. With acute consequences, it is crucial that best practices
are in place to ensure that your recorded data and documentation is compliant when the inevitable inspection comes around.
This interactive, expert-led training course will give you the opportunity to put your current strategies to the test, and bring you up
to speed on the most pressing data integrity challenges, practices and expectations.

Key Takeaways:
- Start at the beginning by performing a GAP analysis of your systems, current capabilities, systems compliance, threats and weaknesses to identify how you need to develop your internal capabilities to transform your informatics systems in the move to ‘Lab of the Future’
- Explore the latest updates in data integrity guidelines and how this is reflected in recent industry trends for compliant data management as you build a risk and usability profile
- Build a data and systems management strategy for LIMS system management and new system implementation to mitigate the risk of losing the integrity of your data during the transfer of records between informatics stakeholders, such as pharmaceutical companies, clinical research organisations and software providers
- Overcome the challenges of data integrity with respect to long-term retention of informatics data – both from internal and external data sources – and documents (archiving)
- Examine the move to Industry 4.0: Making the lab work for you beyond simply storing your data.

Agenda:
10:00 Welcome Coffee and Registration
10:30 Course Introduction and Welcome
10:45 Case Study Overviews
11:15 Networking Coffee
11.45 Discussion-Based Group Work
12:45 Networking Lunch Break
13:45 Discussion-Based Group Work Continued
15:30 Concluding Remarks
16:00 End of Workshop Day