This training session focuses on the Assessment and Monitoring of Stability of reference materials as per ISO 17034:2016 – General Requirements for the Competence of Reference Material Producers (Clause 7.11) and ISO Guide 35:2017 – Guidance for Characterization and Assessment of Homogeneity and Stability (Clause 8).

Key topics covered include:

• Principles and methodologies for assessing both short-term and long-term stability of reference materials.
• Strategies for designing stability studies, including choosing appropriate test intervals and conditions.
• Statistical approaches for evaluating stability data and determining the shelf life of reference materials.
• Practical guidance on monitoring stability to ensure the continued reliability and validity of reference materials over time.

This course is designed for ABs, reference material producers, laboratory managers, and quality assurance personnel who are involved in the production, certification, and ongoing monitoring of reference materials.