Overview
This event highlights the critical role of Performance Verification Testing (PVT) in ensuring the reliability and consistency of dissolution testing systems, and the full coverage of system performance that mechanical calibration alone does not fully cover. We will also discuss on the Consequences of Enhanced Mechanical Calibration vs. Fully Qualifying Dissolution Equipment; why fully qualified dissolution instruments matter.
By attending this workshop, you will be able to:
- Mechanical calibration and PVT are both essential for a fully qualified dissolution instrument.
- The new DPVS formulation is highly sensitive to subtle changes and interactions in instrument setup and operational parameters.
- Instrument-to-instrument variability is a significant factor in dissolution performance, even among mechanically qualified systems.
- Understanding parameter interactions is critical, as individual parameters that pass mechanical calibration do not guarantee overall system performance within acceptance limits
- Identify USP staff and activities in Asia Pacific
Who should participate:
- Lab Personnel in research and development, manufacturing, and production
- Scientists and managers of manufacturing and contract research organizations
- Quality assurance and quality control specialists and auditors
- Regulatory professionals
Led by: Joseph Eaton, Director, Global Standards Distribution, United States Pharmacopeia