In this week, we will review the following subjects
Regulatory Frameworks:
- Overview of FDA, EMA, and WHO guidelines for mRNA vaccines.
- Clinical trial phases and approval processes.
- Post-marketing surveillance and pharmacovigilance.
Quality Management Systems:
- Principles of QMS in biomanufacturing.
- Documentation practices: Batch records, SOPs, and CAPAs.
- Audits and inspections: Internal and external.
GMP Compliance:
- Facility and equipment qualification.
- Personnel training and competency assessments.
- Environmental monitoring and control.
Real-World Application:
- Case study: Regulatory approval process for mRNA COVID-19 vaccines.