Topics
- use of hazard analysis to make validation efficient
- identification of risk and plan risk-mitigations
- risk assessment to reduce validation time
- documentation of risk assessment using a template
- Automatic traceability
- Determining risk in a process to reduce the testing effort
The Risk Assessment-Compliance Using Easy To Fill Out Documentation 2012 brings together attendees from clinical, regulatory, IT and laboratory working in the clinical trial, health care, medical device and biopharmaceutical sectors.
