Consulting Services
Your company or facility can take advantage of consultation services covering the following areas of expertise :
- Internal Audits
- Supplier Audits
- Gap Assessments
- FDA 483 and Warning Letter responses
- FDA 483 and Warning Letter remediation
- Risk-based auditing systems (internal & supplier)
- External regulatory and certification audit support
- Document and Procedure Writing & Review
- Process Optimization
- Management Review
- Regulatory Affairs support
- Mock FDA Inspections
- Design of Experiments (DOE)
- Measurement System Analysis (MSA)
- Test Method Validations (TMV)
- Corrective and Preventive Actions (CAPA)
- Process Validations
- Process Monitoring
- Quality Metrics
- Procedures and Work Instructions
- Sampling Plans (Variable and Attribute)
- Training