51ÁÔÆæ

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

Small or emerging life science organizations often put off hiring quality executives, exposing the company to risk or worse. Other organizations add full-time leaders before they have full-time needs, resulting...

The Sterilization Road Map to Authorization in the EU Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being...

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at 51ÁÔÆæ. Q: Do I need to comply with all aspects of the various...

Subject matter experts from 51ÁÔÆæ Inc. discuss how too many organizations scramble when an FDA inspection occurs because they fail to be adequately prepared. True inspection preparedness, however,...

When it comes to pharmaceutical manufacturing, ensuring a strong quality culture is one way to avoid recurring GMP issues, such as data integrity. Susan Schniepp, Distinguished Fellow at Regulatory Compliance...