Assessing Risk in Seeds & Cell Banks Practices: Avoid Costly Disruptions in Vaccine Manufacturing
Tunnell assessed each risk identified and evaluated its degree of potential impact.
Case Studies
These case studies provide an in-depth look into the challenges some life sciences companies have faced and the methodologies and solutions implemented by Tunnell to solve the problem and provide sustainable results.
Quality Culture: Charting the Path to an Organization-Wide Commitment to Quality, Compliance and Right-First-Time Performance
The client now has a comprehensive roadmap for creating a sustainable Quality Culture.
Fast-Tracking Facilities Start Up: Rapidly Turning Investment into Revenue
The company met — and exceeded — its ambitious goals.
Process Capability and Control: Getting to the Root Causes of Variation – and Saving a Product Line
The company replenished supply to the market and realized a savings of an estimated $2 million annually.
Rapid Process Understanding: Getting to the Root Causes of Revenue-Threatening Product Problems
The team developed a set of formulation-related, process-related and packing-related optimal operating parameters.
Compliance Under Pressure: Rapidly Reducing Deviations and Increasing Right-First-Time – and Sustaining the Improvements
The plant was brought into compliance and continues to generate exceptional results.
Planning for Profits: Getting Organizational Design Right in Biologicals
A new design profitably reshaped the organization and ensured the right behaviors.
Beyond Operational Excellence: Creating a Culture of Cost Improvement
The company realized improvement on the scale and at the speed it needed.
Getting Up to Speed and Staying There: Lean Lab Improvement That Lasts
Tunnell acted as a sounding board, ultimately leaving the client with a sustainable Lean operation.
Analytical Methods Certification: Certifying Analytical Methods to Meet Regulatory Expectations
All 259 reports were found to be compliant with only one minor observation.