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15 May 2007 - The Role of Data Quality in Regulatory Compliance
SAS UK (Headquarters), Wittington House, Henley Road, Medmenham, Marlow, Buckinghamshire, SL7 2EB
Agenda
| 09:00 | Registration, Tea & Coffee | |
| 09:30 | Welcome and introduction | |
| 09:40 | Session 1: It's All About the Data This session highlights the pivotal role of data analysis, data integrity and data mapping in support of regulatory compliance and will explain why simply validating computer systems does not always assure data integrity. | |
| 10:10 | Session 2: Leveraging Data Use in Support of Risk-Based Validation | |
| 10:45 | Morning Tea & Coffee | |
| 11:00 | Research and Development Stream | Manufacturing Stream |
| Session 3a (R&D Stream): Key Issues Surrounding Regulatory Submissions This session will focus on data analysis and data management issues associated with the regulatory submission of clinical data and delegates consider issues including audit trails, trustworthy electronic records and electronic signatures. | Session 3b (Manufacturing Stream): Process Analytical Technology - Trustworthy Process Analysis in support of Product PAT is a very topical issue with pharmaceutical manufacturers and this session will look beyond the type and highlight the need for accurate data analysis to define the control space and assure validity of PAT models. | |
| 11:45 | Session 4a (R&D Stream): Current Trends in Clinical Data Standards | Session 4b (Manufacturing Stream): Production Data Versus Records - Applying 'the new Part 11' |
| Looking at current trends, this session provides delegates with an opportunity to understand the current regulatory position on clinical data standards including de-facto standards such as SAS and industry standards such as C-DISC. | Here is a big difference between production data and production records and after this session delegates will understand the differences between and regulatory significance of production data, management information and regulatory records and the impact of ‘the new Part 11' | |
| 12:30 | Lunch | |
| 13:30 | Session 5: Operational Business Intelligence - Validating Data Warehouses for GxP Use In this session, delegates will discuss the use of data warehouses in their own organizations and how and if these are used to support GxP significant business processes or GxP significant decisions. During this session, facilitators will provide guidance and advice on how to cost effectively validate data warehouses for GxP purposes. | |
| 14:15 | Session 6: Validating Data Management Extract, Transform and Load (ETL) tools | |
| 15:00 | Afternoon Tea and Coffee | |
| 15:15 | Session 7: Data Mapping in Support of Regulatory Compliance | |
| 16:15 | Questions & Answers: Wrap up session to address questions previously submitted by delegates or cover any outstanding questions from previous sessions | |
Objective
Business & Decision organises a regular series of industry workshops in order to:
- Allow the Life Sciences user community to identify common issues in the overlapping areas of business efficiency, regulatory/IT compliance and computer systems validation.
- To provide a forum to discuss these issues.
- To identify and share pragmatic, industry best practice solutions.
- This specific workshop is intended to look at The Role of Data Quality in Regulatory Compliance. The workshop will focus on the Biostatistical techniques in Research and Development, the use of data standards in Clinical Trials and data analysis in the development of PAT (Process Analytical Technology) models.
Workshop Format
Unlike other seminars or meetings, where the majority of time is spent listening to ‘talking heads’, the workshop format is designed to allow maximum interaction between attendees. Facilitated by experienced consultants from Business & Decision and invited industry experts, each session will provide an update on current IS technology and is designed to outline specific issues and to discuss them in an interactive forum. Attendees are invited to prepare for the workshop by considering the relevant issues within their own organisation and how some of these problems are being tackled. Because the objective of the workshop is to facilitate an open discussion of problems and solutions, all information exchanged is treated on a confidential basis and all attendees are expected to respect this principle.
Who Should Attend?
This workshop is intended for those responsible for:Implementing a service oriented IS model,
- The provision of service oriented information systems,
- The validation / qualification or regulatory oversight of IS services,
- The project management of associated projects.
Typically this will include senior management and system owners, quality managers, staff responsible for computer systems validation, CIOs/IT managers and project managers.
What Does It Cost?
Attendance at this event is free of charge. Refreshments and a buffet lunch are provided. Attendees are expected to pay their own travel and accommodation costs.
How Many Places Can I Book?
Attendance from a cross section across the organisation is most beneficial at such a workshop. However, the workshop format works best with representatives from different organisations. Places are limited and are generally allocated on a first come, first served basis and early registration is advised. The organisers may request companies to restrict numbers from their organisation in order to ensure a representative sample from the industry.
How Do I Reserve Places at the Workshop?
Please complete the booking form below.
If you wish to register multiple people from your company please enter their names and contact information in the "Additional Attendees" section. If these people are based at a different address than the one you intend to enter in the "About You" section, we would be grateful if you completed a separate registration form for these people so that we have a record of this additional address.
