Pharmaceutical Training Service Curriculum
Module 1: Pharmaceutical Fundamentals
- Drug development lifecycle
- Regulatory frameworks (FDA, EMA, etc.)
- GMP compliance basics
- Quality management systems
Module 2: Safety and Compliance
- Drug safety monitoring
- Adverse event reporting
- Documentation requirements
- Standard Operating Procedures (SOPs)
- Data integrity principles
Module 3: Manufacturing Processes
- Dosage form types
- Production workflows
- Equipment sterilization
- Contamination prevention
- Batch processing
Module 4: Quality Control
- Testing procedures
- Specification requirements
- Laboratory practices
- Stability testing
- Release protocols
Module 5: Distribution and Storage
- Supply chain management
- Temperature monitoring
- Warehouse requirements
- Transport validation
- Track and trace systems
Practical Components
- Virtual laboratory simulations
- Case study analyses
- SOP writing workshops
- Audit preparation exercises
- Compliance documentation practice
Assessment Methods
- Knowledge checks after each module
- Practical assessments
- Regulatory compliance tests
- Final certification exam
- Continuous evaluation reports
Resources
- Interactive learning modules
- Reference documentation
- Regulatory guidelines
- Industry best practices
- Update notifications
Implementation Guidelines
- Annual refresher requirements
- Competency tracking
- Progress monitoring
- Performance metrics
- Compliance reporting