Displaying 1–25 of 34 results for Tunnell Consulting

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In Defense of the Anti-Generic

(Article)

Authorized generics are the controversial hero of post-patent profitability.

Through the Lens of Lean

(Article)

Lean may have been designed for manufacturing, but it can also transform QC labs, as this case study shows.

Special Report: Reimagining QbD

(Whitepaper)

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.

QbD: Redefining Time to Market

(Article)

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

June 2011 Issue of Pharmaceutical Manufacturing

Beyond the Mandates: Finding Business Value in Mass Serialization and Supply ...

(Article)

Tunnell Consulting’s Carla Reed provides a six-step approach for establishing drug products’ digital DNA, with an eye towards ROI as well as compliance.

Onsite and Online, Interphex Attracting Visitors

(Article)

The annual spring tradeshow has reenergized itself by building a year-round online presence.

Is Pharma Stuck on the Way to Six Sigma?

(Article)

Six Sigma and OpEx now take a back seat to cost-cutting, yet experts say cost reduction will, ultimately, drive the industry’s transformation

Implementing Quality by Design: Are You Ready, or Not?

(Article)

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.

How Lean is Pharma?: A 10-Year Progress Report

(Article)

So much is to be gained, yet it is hard to tell whether any drug manufacturer has truly made progress over the last decade.

Toyota's Meltdown: Lessons for Pharma on its Lean Journey

(Article)

Pharma's Lean Six Sigma efforts are still at an early stage, but Toyota's quality woes offer important lessons

Green Processes: PAT and QbD Take Root

(Article)

Leveraging PAT and QbD promises significant environmental dividends

Flexible Pharma: Puzzling Out the Plant of the Future

(Article)

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.

The Impact of Inventory Turns on Speed, Quality, and Costs

(Article)

By creating low inventory environments, pharma can establish the “Leanness” that it sorely lacks.

Eluding the OpEx Black Hole

(Article)

When it comes to operational excellence initiatives, middle managers are often seen as the problem—a black hole, if you will—but can be the solution.

On Kaizen Events and Other Oxymorons

(Blog)

Are You Crisis-Proof?

(Article)

Tunnell’s 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.

Lessons from Heparin

(Article)

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

Winning the Space Race

(Article)

Complying with ICH Q8 requires knowledge of three key spaces: design, technology and regulatory. Here’s how one company used Design of Experiments to troubleshoot variability in the validation of a controlled-release pain reliever.

Tunnell’s Philippe Cini on Pharma Operational Excellence

(Article)

Reducing inventories is important, but reducing the cost of quality offers far greater return on investment (ROI).

Ten Steps to Process Improvement, Part 2

(Article)

Following a proven framework can get an improvement program off the ground and ultimately, lead to success for managers at all levels.

Prioritizing Goals by Applying Options Thinking

(Article)

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.

Ten Steps to Process Improvement, Part 1

(Article)

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.

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