This course will address the process for World Health Organization prequalification of vaccines. Participants will better understand the laboratory information file and product summary file as well as additional expectations from evaluators and inspectors. The evaluation of vaccines by national regulatory authorities and national control laboratories will also be covered as it relates to the lot release certificate and participation in United Nations vaccine programs. Participants will be engaged in practical exercises and case studies to reinforce learning.

Subject area:
Biologics

Objectives (If applicable):
•Summarize and discuss critical prequalification steps for quality control laboratories
•Describe how to prepare laboratory information files per WHO
•Explain the sections of a product summary file (PSF) per WHO procedures for assessing the acceptability of vaccines purchased by United Nations
•Discuss the purpose and scope of WHO guidelines for the independent lot release of vaccines by regulatory authorities
•Identify and discuss the responsibilities of the vaccine manufacturer, the national regulatory authority and national control laboratories
•Describe details of the lot release procedure and important elements of the lot release certificate
•Discuss the best practices used to monitor vaccine lots

Target Audience (If applicable):

•R&D Manufacturers
•Research Scientists
•Biotechnology Manufacturers
•Pharmaceutical Microbiologists