The conference brochure, including the detailed agenda, can be downloaded HERE.
Pre-Conference Workshops, 22nd April 2020
|12:30hrs||Workshop registration and refreshments
Note: Lunch is not provided
|13:00hrs||An Introduction to GCP for Records Managers and Archivists
Jo Burmester , Director, JoBurmester.com
This will be an interactive session covering the key requirements of GCP focusing on good document management, TMF and archiving. The session will cover ICH GCP (R2), EU and UK clinical trials legislation and FDA legislation. The interactive sessions will be designed to illustrate how the regulatory requirements impact on the roles of document managers and archivists in practice.
|13:00hrs||An Introduction to GLP & GMP for Records Managers and Archivists
David Thompson, Director, Clarity Compliance Solutions
This will be an interactive session covering the key requirements of GLP & GMP focusing on good document management, TMF and archiving. The session will cover UK, EU< and US regulation and legislation. The interactive sessions will be designed to illustrate how the regulatory requirements impact on the roles of document managers and archivists in practice.
Agenda Thursday 23rd April
|09:00hrs||Welcome and Introductions
Dora Endreffy, Chairman, Health Sciences Records and Archives Association
|09:05hrs||HSRAA Annual Review (including Scientific Archivists Group Ltd AGM)
Eldin Rammell, Chairman, Scientific Archivists Group Ltd
|09:30hrs||MHRA Regulatory Update and Discussion
|10:30hrs||Good Documentation Practice -A Key Indicator of Attention to Detail
David Thompson, Director, Clarity Compliance Ltd
In the regulated industries attention to detail through Good Documentation Practice is a fundamental requirement. Our documentation sets maybe large, complex, detailed or maybe simple forms but they must be accurate and capture what is required or what has happened. This presentation will explore some of the common pitfalls and how Good Documentation Practice can provide regulators/auditors a very simple and visible indicator (positive or negative) on the organisational quality culture.
|11:45hrs||Data Integrity Assessments of Computerised Systems: Short Term Remediation and Long Term Solutions
Bob McDowall, Director, R D McDowall Limited
Data integrity is not just numbers and the scope of the programme of work will be explained by a data integrity model. One of key requirements in a data integrity programme is assessment of computerised systems and their remediation which may include both short term procedural fixes and long term solutions involving technical controls and the elimination of hybrid systems. An example of an assessment of a laboratory system will be presented along with the advantages and disadvantages of procedural and technical controls.
|13:30hrs||Foundations of an Electronic Archive: Using the OAIS Reference Model to create a User Requirements Specification
Roxanna Boyd, Archivist, TauRx Therapeutics Ltd
Having a plan in place for electronic archiving can seem like a huge challenge when we consider the scale and variety of electronic records that we need to preserve in health science organisations. The Reference Model for an Open Archival Information System (OAIS) is a document created by The Consultative Committee for Space Data Systems. This reference model is a great place to start when setting up any records archive, but particularly an electronic archive. This session will focus on how the information in this document can be used to create a detailed User Requirements Specification (URS) for an electronic archive.
|14:15hrs||Implementing a full chain of custody strategy that includes physical archives
Christopher Giles. Director, iCompli by LegalRM
Physical archives are an integral part of a company's information governance strategy. This session talks about why full chain of custody of physical archives is important as well as address a joined up approach to the adoption of physical and electronic retention and disposition policy.
|15:30hrs||Measuring progress in digital preservation using DPC's Rapid Assessment Model
Jenny Mitcham, Digital Preservation Coalition
The Digital Preservation Coalition has recently developed a new maturity model which is freely available for organisations to use to measure their current position and future goals in digital preservation. The Rapid Assessment Model (DPC RAM) can be used by any organisation, in any sector, who is required to manage digital content for the long term. This presentation will introduce the model and describe how it is being used across the world to help information managers and archivists manage their valuable digital assets into the future.
|17:00hrs||Complimentary Drinks Reception for delegates|
Agenda Friday 24th April
|09:00hrs|| How to talk about Records Management so people will listen
Jo Burmester, Training Consultant, joburmester.com
One of the biggest challenges in records management is getting operational colleagues to do what needs to be done. This session will provide some hints and tips on communicating with How to talk about Records Management so people will listen colleagues and clients so that they will understand the importance of records management and buy in to what you need from them more readily.
|09:45hrs||“For every minute spent in organizing, an hour is earned” (Benjamin Franklin)
Kath Firth, Head of Quality Operations, GlaxoSmithKline
Tara Isherwood, Senior Director, Real World Clinical Consulting, Syneos Health Commercial Solutions
When filing documents, a good document management plan is the foundation that enables efficient and compliant document management. Setting up a document management approach involves setting up a document management plan or reference model to guide users. Successful document management plans establish the rules for creating, storing, retrieving and securing documents. A successful reference model establishes an efficient process for classifying, categorizing and filing documentation. Over the last 18 months, a group of subject matter experts from across industry have collectively worked on establishing a reference model derived from the clinical trial approach to serve as a reference model for managing the documentation for Real-World studies. This presentation explores the power of collective thinking, diversity of experience and our journey from idea to an agreed perspective.
|10:15hrs||Implementing New Technologies
Marc Smith, Head of Operational Technology and Informatics, Lonza
Using the introduction of electronic laboratory notebooks as an example, this presentation will explore best practices for introducing new technologies covering implementation challenges, potential to improve data integrity, and opportunities to enhance information sharing and to facilitate collaborative working etc
|11:45hrs||Out with the Old, In with the New
Dora Endreffy, Global Records Manager, ICON plc
Throughout their careers, Records Managers and Archivists will inevitably be faced with decisions regarding systems retirement. The retirement of computer systems is an integral component of the validation lifecycle and should be conducted in accordance with well-defined and documented processes. Whilst the adoption and use cycles of validation are well understood, when systems are retired there is less understanding of the consequences. This presentation will examine the challenges associated with systems retirement, provide recommendations and tools for retirement including risk assessments, and lessons learned from experience of retiring LIMS and CDMS.
|13:30hrs||Quality Management Systems, Records Management and Archiving: Joining the Dots
Matt Scotney, Director, Quality Systems and Compliance. Autolus Ltd
Total quality management aims to ensure that employees are ever mindful of the need to focus on improvements in work culture, processes, services, and systems etc to ensure the safety, efficacy and quality of the medicines produced and the quality and integrity of the data used to evidence compliance. This presentation will examine how quality management and records management work hand-in-hand to establish and maintain controls over information creation and flow, govern day-to-day operations, and ensure that the organisations functions effectively and compliantly.
|14:15hrs||“Quality means doing it right when no one is looking.” (Henry Ford)
Divya Chotai, TMF Specialist, Autolus Ltd
Russell Joyce, Director, Heath Barrowcliff Consulting Ltd
Among the most fundamental principles of good record-keeping in life sciences are the ability to provide documentary evidence of compliance with the requirements to protect patient safety, patient rights, and patient well-being; to ensure product quality and product efficacy; to demonstrate data integrity and trial integrity; and to maintain appropriate oversight. This presentation will explore how to use quality controls to deliver optimum levels of comprehensiveness and quality in relation to data, document, and records management.
|15:30hrs||Close of Conference
Dora Endreffy, Chairman, Health Sciences Records and Archives Association
Note: Tea/coffee and pastries will be available at the close of the conference before departure.