Key topics covered include:
- Data integrity: Experience from GMP practice (laboratory, IT systems, production, documentation) and new expectations in field.
- Environmental monitoring: incubation strategies ; Deviations in results and impact on further decisions with respect to batch release.
- Batch release and deviations – QP perspective.
- Best practice in the effective management of sterility test failures.
- Practical approaches to microbiological audits – hosting an audit.
If attending from overseas – book and receive automatic individual membership to the end of December 2017
