Regulation and Compliance - BioPharm International


Regulation and Compliance

Quality by Design and Compliance Readiness

January 1, 2010

How will implementing Quality by Design strategies affect your compliance status?

The Promise and Perils of Vaccines

December 1, 2009

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

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.

Safety First in Biotech Development

November 1, 2009

Heightened attention to product safety issues is slowing the approval process for new therapies.

FDA Leaders Stress Science and Compliance

October 1, 2009

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena

September 1, 2009

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.

Health Reform Challenges Biotech Industry

August 1, 2009

Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.

How to Shift from Reactive Compliance to Strategic Quality Management

July 1, 2009

A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.

Extended Risk Management Proposals Challenge Manufacturers

July 1, 2009

The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.



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