ISPE DIA Workshop on Computer Systems Compliance 2014

Key Topics

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

Who should Attend

Intermediate and experienced professionals from:

• Staff from clinical science and clinical operations
• The pharmaceutical industry and Contract Research Organisations including:
• Regulatory affairs personnel
• Monitors, auditors of clinical trials
• Research and clinical quality assurance staff
• Information Technology and CSV practitioners
• IT service provider organisations
• Regulatory agencies
• Academic institutions