Displaying 1–25 of 34 results for Tunnell Consulting
Authorized generics are the controversial hero of post-patent profitability.
Lean may have been designed for manufacturing, but it can also transform QC labs, as this case study shows.
Pharmaceutical Quality by Design has entered a new era-one of fading skepticism and accelerated uptake. Now that the industry has bought in, the challenge is to rethink the possibilities of what benefits QbD can provide.
For manufacturers who lack formulation and process knowledge, the benefits of getting to market fast can be outstripped by the costs of unexpected failures.
June 2011 Issue of Pharmaceutical Manufacturing
Tunnell Consultings Carla Reed provides a six-step approach for establishing drug products digital DNA, with an eye towards ROI as well as compliance.
The annual spring tradeshow has reenergized itself by building a year-round online presence.
Six Sigma and OpEx now take a back seat to cost-cutting, yet experts say cost reduction will, ultimately, drive the industrys transformation
The question is not whether Quality by Design is ready to help you solve the perennial challenges of drug development and manufacturing, but whether you are ready for it. Tunnell's Bill Schmidt pinpoints what exactly makes some drug manufacturers "ready" for QbD, and others not.
So much is to be gained, yet it is hard to tell whether any drug manufacturer has truly made progress over the last decade.
Pharma's Lean Six Sigma efforts are still at an early stage, but Toyota's quality woes offer important lessons
Leveraging PAT and QbD promises significant environmental dividends
The need to improve agility and reduce financial risk is driving new approaches to plant design and operation, and the use of new technologies. Industry experts look at the future pharmaceutical plant from all angles.
By creating low inventory environments, pharma can establish the Leanness that it sorely lacks.
When it comes to operational excellence initiatives, middle managers are often seen as the problema black hole, if you willbut can be the solution.
Tunnells Jaime Velez offers advice for manufacturers wary of where their raw materials are coming from and what preventive measures they can put in place to avoid their own crisis.
Avoiding future drug quality disasters will require closer control over raw materials, use of more powerful analytics and IT, and a Quality by Design approach
Complying with ICH Q8 requires knowledge of three key spaces: design, technology and regulatory. Heres how one company used Design of Experiments to troubleshoot variability in the validation of a controlled-release pain reliever.
Reducing inventories is important, but reducing the cost of quality offers far greater return on investment (ROI).
Following a proven framework can get an improvement program off the ground and ultimately, lead to success for managers at all levels.
Manufacturing decisions are complex and fraught with risk. Applying systematic methods can improve results and increase value, whether on the corporate or on the local operational level.
In this first part of a two-part series, Tunnell Consulting principal Ron Snee outlines how mid-to-senior-level managers can make Six Sigma part of their daily lives.