Good Manufacturing Practices are the foundation for all drug and biologic products intended to be dosed to humans. Sponsors are legally required to follow GMPs in their manufacturing processes. It’s recognized that early clinical trials involve a small number of subjects and require a small amount of product. And, at this early stage, could present undue investment burden for sponsors to comply fully with all GMPs. Therefore, provisions have been made to use a risk-based approach across phases of development. This workshop will provide details for you to ensure GMP compliance.
KEY AREAS COVERED:
- Core principles of GMP Regulatory requirements across phases
- Raw material requirements and process development
- Quality Assurance Required
- Batch records
- Practical exercise: Review a batch record and perform quality control
- Manufacturing process development & scale-up
- Method development
- Vendor Oversight
- Practical SOPs
- Quality & Content Req IND/CTA/IN Practical eCTD content
- Qualification vs. Validation
Peggy J. Berry, President & CEO,
Synergy Consulting and Executive Regulatory Lead, 3D Communications
We look forward to seeing you in Orlando this Chilly Winter!