The ISPE DIA Workshop on Computer Systems Compliance 2014 covers topics such as:
- 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
The ISPE DIA Workshop on Computer Systems Compliance 2014 brings together 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