Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing safe and effective pharmaceutical and biotech products.
A one and a half day course covering GMP essentials including: - History of US GMPs
- International Regulatory Authorities and Regulations
- Regulations and Guidelines
- Personnel and Organization
- Buildings, Facilities, and Utilities
- Equipment
- Materials Management and Supplier Controls
- Manufacturing and Packaging
- Labels and Labeling
- Laboratories and Testing
- Storage and Distribution
- Records and Documentation
- Risk Management
- Validation
- Quality Management Systems
- Change Management
- US FDA Inspectional Process
