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Quality Management Consulting

Quality System Implementation
Hosting Regulatory Inspections
Writing Observation Responses
Identifying Systemic Quality Issues

Quality Auditing

Internal Audits
Supplier Audits
Mock Inspections

Quality Training

Regulatory Inspections
Computerized Systems Validation
Software Configuration and Design
Electronic Records and Data Management
Preventing and Identifying Data Integrity Issues
Good Documentation Practices
Deviation Investigations and Root Cause Analysis
CAPAs and Effectiveness Checks
Biological Product Deviation Reporting
Quality Agreements
Risk Assessments