📚 Syllabus & Course Curriculum
Drug Discovery & Pharmaceutical Sciences
Module-by-module breakdown of GxP, Regulatory Affairs & Documentation for Biopharmaceuticals, from foundations to a certified capstone project.
Framework
• GLP, GCP and GMP and the distinct activities each governs
• ICH Q7 to Q12 and the quality system expectations behind them
• Regulator roles: CDSCO, FDA and EMA and where their requirements diverge
Data Integrity
• Attributable, legible, contemporaneous, original and accurate, plus the additions
• Audit trails, 21 CFR Part 11 and computerised system validation
• Data integrity findings as a leading cause of warning letters
Documentation
• Batch records, SOPs, protocols and reports and their approval routes
• Good documentation practice: corrections, signatures and contemporaneous entry
• If it is not written down it did not happen, applied literally
Quality Events
• Deviation handling, root cause analysis and CAPA that addresses the cause
• Change control and its assessment of regulatory impact
• Internal audit, inspection readiness and responding to observations
Submissions
• CTD and eCTD structure and what populates each module
• IND, BLA and marketing authorisation routes for biologics
• Biosimilar comparability and the additional demands of cell and gene therapy
Earn government-registered certification in GxP, Regulatory Affairs & Documentation for Biopharmaceuticals
e-Certificate and e-Marksheet issued on successful completion.
