Resources

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and/or maintaining a robust and comprehensive global Quality Management System (QMS).

The purpose of this paper is to discuss the evolving methods to test toxicology in ways that minimize the negative impact on animals as much as possible.

Good Manufacturing Practice (GMP) Maintaining good quality control practices throughout the entire manufacturing process requires robust GMP development, a drive toward product and process understanding, and pre-established, comprehensive written procedures...

How careful planning and the smart use of human capital and other resources can result in a risk-based strategy that delivers organizational results for a Quality System.

Insights on driving value from staffing, automation and continuous improvement. Developing a quality management system is the foundation for ensuring the organization’s products or services are safe, effective and controlled...

Q: I saw where FDA released draft guidance on data integrity. In the guidance, the answer to question 16 says personnel should receive cGMP training to detect data integrity issues...