READINESS ASSESSMENT
Readiness assessment
Identify the gaps most likely to matter during an inspection.
- Quality system review
- Risk-based gap assessment
- Records and documentation review
- Inspection risk prioritization
LH QUALITY CONSULTING
FDA Inspection Readiness Consulting
Get your quality system, documentation and team ready before an FDA or other regulatory inspection. LH Quality Consulting provides risk-based, hands-on preparation and support.
MOCK INSPECTION
Mock inspection
Practice the inspection experience and identify weaknesses before regulators arrive.
- Mock interviews
- Document retrieval exercises
- Inspection simulations
- Observation and finding preparation
RESPONSE & REMEDIATION
Response & remediation
Help your team address findings and follow-up actions.
- CAPA support
- Remediation planning
- Inspection response support
- Evidence and effectiveness review
NEED QUALITY SUPPORT?