BioPharm International-05-01-2009

Use Lean techniques to improve manufacturing compliance

Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.

How to optimize facility utilization and improve plant performance.

Several legal considerations are key to protect the buyer and seller in royalty interest transactions.

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

Why the industry needs to review its traditional approach to facility validation

It is essential to build and maintain a good working relationship between the client and contract research organization.

The current competitive environment is forcing service providers to evaluate their business models and focus on value and performance.

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Authorities are pushing for CE; manufacturers prefer to focus on value.