Course Description:
This four-hour 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.
Upon completion of this course, you will be able to
- 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
Who should participate:
- R&D Manufacturers
- Research Scientists
- Biotechnology Manufacturers
- Pharmaceutical Microbiologists
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Victor Maqueda
USP Consultant
Biologist/Professor of Biological Sciences