Results

Session 9: Quality Management and Prequalification Session Objectives • Place international standards within quality management context • Discuss intent and scope of key quality management…

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 7: Product Safety and Biocompatibility Issues Session Objectives • Understand safety and biocompatibility requirements for prequalification per the WHO Specification • Identify required…

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 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 4: Preparation of a Site Master File (SMF) Summary for Condom Prequalification Session Objectives • Provide overview of all necessary components of a Site Master File (SMF) Summary •…

Session 3: Preparation of a Product Dossier for Condom Prequalification Session Objectives • Give overview of all necessary components of a Product Dossier • Identify key reference documents •…

Session 2: Overview of the WHO Prequalification Programme for Condoms Session Objectives • Introduce the key differences between the new and old WHO/UNFPA prequalification scheme • Understand the…

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: Prequalification and Procurement Session Objectives • Discuss aims of the World Health Organization (WHO) Prequalification Programme • Explain the role of the United Nations Population…