|
- cGMP auditing
- Quality Systems development and review
- Laboratory Control Systems
- Out-of Specifications procedures and Investigation reviews/assistance
- Deviation Investigation reviews/assistance
- Annual Product Reviews
- Batch Record review and Product Release procedures
- Assistance with developing responses to Agency (FDA and EU) compliance observations
- Follow-up services for corrective/preventive actions resulting from internal, contract or Agency
audits
- Equipment/Operational SOP's
- Process Development
- Process Optimization
- Emulsion Technology
- Facility Improvements
- Technical and Process Troubleshooting
- Validation Protocol reviews
- Process/Product transfers and scale-ups
- Computer systems validation audits
- Computer system life-cycle SOPs
|
