Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP 2011 will cover the following topics:
- GCP and clinical laboratories
- Standards
- Assess of a clinical laboratory
- Facilities suitability
- Procedures
- Documentation - validation, SOPs, technical agreements
- The laboratory and the sponsor contract
- Analysis of final reports
The event brings together FDA and EMA regulated companies using clinical laboratories such as biotechnology, pharmaceutical and biologics products companies.