This seminar will provide an interactive approach to understanding the new GAMP Good Practice Guide:
The Guide offers a pragmatic approach, based on a criticality assessment, to provide effectiveness and regulatory compliance as cost effectively as possible.
Revision of the Calibration Management Good Practice Guide:- Update and Status: - Focused calibration effort concentrating on regulatory risks and patient safety
- Software systems for supporting calibration both as scheduling and data record tools
- Internal and external auditing of systems and the use of supplier systems and documentation
- Guidance on the application of errors of uncertainty calculations and Assumptions
- Physical labelling and tagging schemes
- Risk based interval setting
- Reference standards and traceability
- Tolerance, Alert and Action limits
- Adjustment (within range, out of range)
