This course provides a general overview of manufacturing and characterization of vaccines including vaccine types, components, and functions. Fundamental concepts of good manufacturing practices (GMPs) will be introduced to participants. USP general chapters, International Council for Harmonization (ICH) and World Health Organization (WHO) regulatory guidelines, and vaccine standards developed by the WHO Expert Committee for Biological Standardization will also be addressed. Participants will engage in practical exercises and case studies to reinforce key learning points.

Subject area:
Biologics

Objectives (If applicable):
•Identify and discuss the main good manufacturing practice (GMP) principles for pharmaceutical products and the pharmaceutical quality system according to the WHO
•Discuss the impact of critical changes on product quality through practical exercises
•Describe the lifecycle approach and expectations for GMP production of biological products in terms of the WHO Demonstrate a basic understanding of the types of vaccines and their components through discussion and recall activities
•Summarize and discuss the vaccine manufacturing processes
•Explain the fundamental concepts of GMP
•Define the components of SISPQ
•Summarize the importance of the ICH and WHO
•Identify and explain ICH guidelines—Q5B, Q5D
•Explain ICH Q7, Q8, Q9, and Q10 as they relate to pharmaceutical quality systems (PQS)
•Demonstrate and apply knowledge of quality risk management and PQS through practical exercises and/or case studies

Target Audience (If applicable):
• R&D Cell Biologists
• R&D Manufacturers
• Research Scientists • Biotechnology Manufacturers
• Pharmaceutical Microbiologists