Resources

Employees from the U.S. Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) recently announced partnerships with new collaborative communities in the life sciences industry. A...

In the second episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality...

Experts share insights on what the future may hold regarding biotech quality, regulatory requirements and quality standards for biotechnology industry. The biotech industry has experienced significant growth in recent years....

The main regulatory standard for ensuring pharmaceutical quality is 21 Code of Federal Regulations (CFR) Parts 210 and 211, collectively referred to as the current good manufacturing practice (CGMPs) regulation...

A well-written and well-implemented quality risk management plan is an integral element of an effective quality system. During the development of your total quality strategy, the bottom line is that...

Insights about what works and what doesn't in managing a product crisis, learned from real investigations of product failures.