This course shows how to review batch records the way regulators expect - practical, defensible, and inspection-ready - so product release decisions are confident, consistent, and audit-proof.
You’ll understand what regulators actually expect when they look at executed batch records, how reviewers should be trained and qualified, and how Quality and Production must work together without friction. We’ll break down what to look for line-by-line, how to handle discrepancies confidently, and how to document decisions that hold up during audits, investigations, and product release.
If your batch records come from internal manufacturing or CMOs, this session will sharpen how you assess completeness, corrections, raw material usage, and unresolved issues - before they become inspection observations. Practical, realistic, and directly applicable, this is a must-attend for anyone responsible for batch review or release decisions.
Why This Training Matters
Batch record review isn’t paperwork. It’s the final gate between a compliant product and a regulatory nightmare. One missed entry, one unexplained correction, or one poorly trained reviewer can delay release, trigger deviations, or invite inspection findings you never saw coming. This webinar focuses on how batch records should be reviewed in real pharma, biologics, and medical device operations - not theory, not checklists copied from SOPs.You’ll understand what regulators actually expect when they look at executed batch records, how reviewers should be trained and qualified, and how Quality and Production must work together without friction. We’ll break down what to look for line-by-line, how to handle discrepancies confidently, and how to document decisions that hold up during audits, investigations, and product release.
If your batch records come from internal manufacturing or CMOs, this session will sharpen how you assess completeness, corrections, raw material usage, and unresolved issues - before they become inspection observations. Practical, realistic, and directly applicable, this is a must-attend for anyone responsible for batch review or release decisions.
Course Content
- Regulatory intent behind batch records under 21 CFR Parts 210 & 211
- What inspectors expect during batch record review and product disposition
- Reviewer qualifications, training, and readiness criteria
- Handling discrepancies, deviations, and undocumented corrections
- Alignment between Production and Quality reviewers for clean release decisions
- Review of critical quality attributes and critical process parameters
- Batch records from CMOs and shared responsibility challenges
- Documentation practices aligned with ICH Q10 and ISO 13485 for defensible release
Speaker
Danielle DeLucy, MS, brings 15+ years of hands-on QA leadership across pharma and biologics. She has led batch review programs, supported sterile operations, guided companies through inspections, and helped organizations recover from warning letters by fixing quality systems where it truly matters.Who Should Attend
- Quality Assurance Departments
- Manufacturing Departments
- Validation Departments
- Documentation Departments
- Production Departments
- All professionals who review batch records
