Quality Infrastructure and Business Processes
- Quality system development (e.g., GMP, GLP, GCP, 21 CFR part 820, ISO 13485)
- FDA 483/warning letter remediation support
- Client representation at external audits
- Risk and operations assessment
- Audit program design and implementation
- Investigations/complaints
- Quality/operational problem resolution
- SOP review and development
- Change control process development
- Compliance and operations training
- Compliance/quality problem resolution
- QA/QC oversight: e-submissions, data migration, system integration/validation
- CMC support