Session 5: ISO 4074, the WHO Specification, and Related Standards Session Objectives • Understand why ISO standards and the WHO specification are requirements for prequalification • Identify…
Session 6: Shelf Life Objectives • Review the ISO/WHO shelf life and stability requirements • Discuss problems of shelf life in the distribution chain • Discuss how to conduct real-time stability…
Session 7: Product Safety and Biocompatibility Issues Session Objectives • Understand safety and biocompatibility requirements for prequalification per the WHO Specification • Identify required…
Session 8: Sampling and Acceptable Quality Limits (AQL) Objectives • Understand what you can infer from sample testing • Understand how to choose a sample size and make inferences about the…
Session 9: Quality Management and Prequalification Session Objectives • Place international standards within quality management context • Discuss intent and scope of key quality management…
Session 10: The UNFPA Prequalification Site Inspection Group Brainstorm: Site Inspection • In your experience, in what areas have you disagreed with the inspectors? Objectives • Provide overview…
Session 1: Changing Trends in Supply and Demand for Reproductive Health Supplies Projected Need • Need for reproductive health (RH) supplies is increasing at a rapid rate • Financing comes from…
Session 2: Overview of the WHO Prequalification Programme Prequalification • In principal: A documented process for reviewing a product or service to ensure it complies with identified criteria WHO…
