Project Briefs
Tunnell has been involved in thousands of successful projects. Here is a sampling of the accomplishments many companies have been able to achieve using our proven methodologies and best practices.
PAI Preparation and Readiness
- PAI Support
For a successful outcome, it was instrumental to not only identify problems but to identify and implement corrective actions to resolve the underlying problems.
New Facility Preparation for Pre-Approval Inspection
- PAI Support
A culture of continuous improvement and optimization was achieved along with a definitive understanding what it means to be “inspection ready” at all times.
Bio-Facility Qualification, Start-Up & Licensure
- PAI Support
A Tunnell ‘core’ team of functional area SMEs conducted a rapid risk assessment and developed a detailed implementation plan for the qualification, start up
Analytical Method Validation PAI Readiness / Certification
- PAI Support
The manufacturer had been cited on several 483’s for inadequate analytical method validation.
Microbiology Lab Remediation and Process Improvement
- Biotech Support
Results led to marked improvement in throughput and a significant decrease in investigations.
Compliance Remediation
- Quality, Regulatory, Compliance
Over 8500 SOPS reviewed and revised; approximately 125 SOPs eliminated or streamlined.
Lean Lab and Cost Reduction
- LEAN SIX-SIGMA / BUSINESS TRANSFORMATION
Throughput time dropped from 15 days to 8, an improvement of 53 percent.
Manufacturing Capacity Increase via Cycle Time Reduction
- Turnkey Solutions
The client learned how to reduce cycle time without a significant investment.
Manufacturing Process Reliability: Reducing Process Interruptions
- MANUFACTURING PROCESS IMPROVEMENT
Savings from reduced product loss totaled $850K over a 6-month period.
Product Launch Capacity Planning and Modeling for Improved Probability of Success
- MANUFACTURING PROCESS IMPROVEMENT
After the project a sense of urgency was sustained.
Technical Transfer / Consent Decree Remediation
- Technical Expertise
Successful product launch with projected $59M sales forecast.