Compliance Notes - BioPharm International


Compliance Notes

Auditing by the Numbers

January 1, 2012

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Developing and Sustaining a Quality Culture

November 1, 2011

In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.

Following Our Own Instructions

September 1, 2011

Why SOPs are rarely followed, often cited, and in great need of follow-through.

Impact of cGMP on Supply Chain

July 1, 2011

Incorporating regulatory requirements into the product life cycle is crucial.

Quality by Design: The Case for Change (Part II)

May 1, 2011

A rigorous cost-benefit assessment can help to chart a cost-effective path forward.

Quality by Design: The Case for Change

March 1, 2011

Executive management leadership is essential in the effective implementation of QbD.

Quality Management Systems for Small Biopharmaceutical Organizations

September 1, 2010

What small biotechs need to know about quality management systems.

How to Reduce Unnecessary Compliance Costs

July 1, 2010

By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.

QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work

November 1, 2009

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.



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