The conference brochure, including the detailed agenda, can be downloaded HERE.

Pre-Conference Workshops, 22nd April 2020

Time	Description
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 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

Time	Session Description
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 Martin Reed, GLP & GMP Inspector It is a pleasure to welcome Martin Reed back to our conference, following his excellent update on data integrity at our 2017 conference in Manchester.
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.
12:30hrs	Lunch
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.
16:15hrs	Debating Sessions
17:00hrs	Complimentary Drinks Reception for delegates
19:30hrs	Networking Dinner

Agenda Friday 24th April

Time	Session Description
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.
12:30hrs	Lunch
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.

End.