Regulatory/GMP Compliance

Jan 01, 2010
BioPharm International
QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
Jan 01, 2010
BioPharm International
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
Jan 01, 2010
BioPharm International
How will implementing Quality by Design strategies affect your compliance status?
Dec 18, 2009
BioPharm International
Best methods to monitor product-related impurities throughout the production process.
Dec 01, 2009
BioPharm International
Do we really have to choose between saving money and saving time?
Dec 01, 2009
BioPharm International
Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.
Nov 01, 2009
BioPharm International
Heightened attention to product safety issues is slowing the approval process for new therapies.
Nov 01, 2009
BioPharm International
Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.
Nov 01, 2009
BioPharm International
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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