Course Description:
This one-and-a-half-day course will provide International Council for Harmonization (ICH) and World Health Organization (WHO) guidelines related to vaccine manufacturing and other sterile biologics, including manufacturing process controls and pharmaceutical validation. Guidance on USP standards in vaccine production will also be covered. Participants will engage in practical hands on exercises and case studies to reinforce key learning points.
Upon completion of this course, you will be able to:
- Identify and discuss the main good manufacturing practice (GMP) principles for pharmaceutical products and the pharmaceutical quality system according to the World Health Organization (WHO)
- Summarize and discuss the main recommendations of WHO TRS 996, Annex 5, WHO TRS 961, Annex 6 and TRS 992, Annex
- Identify the impact of critical changes to product quality through practical application and exercises
- Describe the lifecycle approach and expectations for GMP production of biological products according to the WHO
- Demonstrate proficient knowledge of validation principles according to the World Health Organization
- Identify and describe the main aspects and approach of the FDA Guidance for Industry Process Validation
- Summarize and discuss critical aspects related to control of equipment, processes, and premises as it relates to validations
- Identify GMP principles according to ICH Q7 and USP general chapters for vaccines and biological products
- Summarize and discuss ICH Q9 and Q10 guidance
- Describe viral safety during manufacturing of vaccines according to ICH guidelines and USP General Chapters
Who Should Participate:
New recruits in he industry with at least 1 year of experience including:
- R&D Cell Biologists
- 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