What is adulteration?
- Pharmaceuticals
- Biologics
- Medical Devices
What is CGMP?
- Pharmaceuticals
- Biologics
- Medical Devices
What is GLP?
- Contract Laboratories
- FDA inspection methodology
Laboratory Organization
- Organization
- Personnel qualification and training
Documentation and record-keeping requirements
- Standard Operating Procedures
- Analytical Methods
- Raw data (notebooks, print-outs)
- Document management (change control, retention)
- Part 11 (electronic records and signatures)
Sample integrity requirements
- Sample collection
- Sample delivery, handling, disposition
- Retain samples
Stability (shelf-life) studies
- Organization and management
- Storage units
- Analytical methodology
Analytical methods verification and validation
- Protocols
- Tests
- Documentation
Management and control of laboratory instruments
- Qualification
- Calibration
- Maintenance
Management and control of laboratory supplies
- Standards
- Reagents, chemicals
Proper conduct of laboratory investigations
- Out-of-specification results
- Out-of-norm results
- Root cause analysis
- Documentation
Consequences of Laboratory non-compliance
Interactive Discussions and Q&A Session