GMPs for All Phases - Ensuring GMP Compliance - 2018 Workshop by Ex-FDA Official covers topics such as:
- Raw material requirements and process development
- Core principles of GMP Regulatory requirements across phases
- SOPs
- Quality Assurance Required
- Manufacturing process development & scale-up
- Batch records
- Qualification vs. Validation
- Method development
- Validation Requirements across regions & phases of study
- Discussion & Review: Qualification vs. Validation
- Vendor Management & Oversight
- Vendor selection & management
- SOP Development & Evolution
- Training Requirements
- Life cycle management considerations; document granularity
- Quality & Manufacturing Content Requirements for the IND/CTA/INDS – in CTD format
- Considerations for Setting specifications and expiring / re-test dates
GMPs for All Phases - Ensuring GMP Compliance - 2018 Workshop by Ex-FDA Official brings together senior attendees from:
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Documentation Departments
- Production Departments
