Corrective Action is often an eff ective means of identifying and correcting quality and compliance events within the organization that can arise through the result of complaints, audits, incidents, nonconformances, or...
Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a common goal, the medical device regulatory approval process can be...
Considerations for Extending the Quality System Beyond Your EnterpriseToday's rise in globalization means that the Life Sciences market is operating on a grander scale than ever before. Life Sciences organizations...
FDA compliance has been much more difficult to deal with.