We offer a wide range of customizable solutions that are led by our senior consultants each with over 15 years experience in pharmaceuticals and project management.
Training
- Customized courses
- How to perform root cause analysis
- Technical writing (with emphasis on either SOPs, protocols, or investigations)
- How to onboard employees
- How to supervise in a cGMP environment
- Train employee educators
- Performing effective database searches (for particular systems)
Compliance Remediation
- Deviation/Complaint investigations
- Trend investigations
- CAPA development and implementation
- SOP creation and revision
- Batch record creation and revision
- Annual Product Reviews
- Training program assessment and development
- Quality Systems design (documentation, CAPA, CC, deviations)
- Documentation services
Validation/Qualification
- Equipment installation/modification
- Process validation
- Media fill studies
- Environmental qualifications (clean rooms, climate controlled spaces, etc.)
- Equipment re-qualifications
- Spreadsheet application validation
Operational Excellence
- Process mapping
- Kaizen team facilitation
- Throughput defect-rate analysis
- Equipment set-up/operation optimization
- Manufacturing process optimization
- Designing Right-First-Time programs
We offer four areas of specialty all of which can be combined to provide a comprehensive turn-key service. Our turn-key service allows for one of our lead project managers to step in and organize all aspects of a project from start to finish.