15th September - 17th September 2020
Frankfurt, Germany

Russell Joyce

Committee Member HSRAA

Russell is the director of Heath BarrowCliff Consulting Ltd, an independent consultancy specialising in records management and information governance in the healthcare and life sciences sectors. He has experience in banking, professional services sector, legal sector, central and local government, and spent many years working in evidence management at the Serious Fraud Office. His particular interests are in evidential weight of documents, and utilising technologies to maximise operational efficiencies and improve data integrity. Russell is an Executive Committee Member of the Health Sciences Records and Archives Association (HSRAA), Co-Lead for the HSRAA GCP Special Interest Group, active member of the Drug Information Association (DIA) TMF Reference Model Group Steering Committee Co-Chair of the DIA Document and Records Management Community, Project Lead for the DIA Non-Interventional Studies TMF Model Project, and former Executive Committee Member of the Good Clinical Practice Records Managers Association (GCP-RMA).Russell has spoken extensively on a wide range of records management and data governance issues for HSRAA, GCP-RMA, SMi Group, DIA, the Research Quality Association (RQA), Pharmaceutical Quality Group (PQG), ISPE/GAMP, and the Institute of Clinical Research (ICR).

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

Main Conference Day One

Sunday, November 11th, 2018

4:00 PM DEALING WITH THE LEGACY SYSTEMS PROBLEM

- Discuss the growing proliferation of legacy data and legacy systems which pose a threat to your data integrity
- Build a data transfer strategy that prioritises data validation before migration
- Examine the ongoing challenge of new systems versus legacy integration and how team education can help to build compliance in the utilisation of
multi-platform systems

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

Download The Latest Agenda