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ISPE/DIA Workshop Computer Systems Compliance

Juli 5, 2017 @ 12:00 am

Data integrity surrounding computerised system-supported business processes throughout the product lifecycle has been at the forefront of recent news, for example Ranbaxy in the USA. The awareness of these issues has changed the approach used by both EU and US regulators in conducting inspections in recent years. As data integrity increasingly becomes a focus of the regulatory authorities, the industry has to recognise and ensure controls for data integrity are implemented and appropriately managed throughout the entire lifecycle of the data. Problems with data integrity manifest themselves differently in each phase of the lifecycle. Therefore, improvements must be managed differently during each phase, based on business risk.

This 2-day conference will provide a forum for information, discussion on conceptual and practical questions and experience exchange through lectures, panel discussions and interactive workshop sessions. It will focus on the work being conducted by two leading organisations within the life sciences sector who approach the subject from differing directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient. It will focus on well-established approaches, similarities of key principles and practices, and challenges associated with new technologies, such as cloud computing.

Key Topics
• The regulatory perspectives on data integrity and the use of new technologies
• The principles of GAMP® 5 and its relationship to clinical systems
• Understanding Business Process Risk Management
• Maintaining data integrity
• The challenges to the industry and regulators of emerging computing strategies such as the use of mobile and cloud-based platforms

Participants will:
• Gain an awareness of the principles of the GAMP® 5 risk-based approach to compliant GxP computerised systems and how they support the maintenance of data integrity
• Understand the principle regulatory concerns and how they may be addressed
• Discuss and identify the key challenges and opportunities of the new technology
• Recognise how companies and industry organisations are developing principles and practical advice to meet these challenges to data integrity throughout the entire product lifecycle
• Have the opportunity to exchange views between regulators, industry and other stakeholders

Who Will Attend
This conference is aimed at intermediate and experienced professionals from:
• The pharmaceutical industry and Contract Research Organisations including:
• Staff from clinical science and clinical operations
• Monitors, auditors of clinical trials
• Regulatory affairs personnel
• Information Technology and CSV practitioners
• Research and clinical quality assurance staff
• Regulatory agencies
• IT service provider organisations
• Academic institutions
• GXP compliance professionals

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Juli 5, 2017
12:00 am