Description
This quarterly newsletter provides over 15 charts and graphs providing clear graphical data highlighting current regulatory trends for pharmaceuticals and medical devices. An executive summary provides a synopsis of all data presented in the newsletter and significant points of interest highlighting changes in regulatory trends. Current Good Manufacturing Practices, Packaging and Clinical categories are reported followed by identification of the top 8 citations each for pharmaceuticals and medical devices. Active links to all Warning Letters for the 2 yr time period reported are provided as well as links to FDA regulations for easy reference eliminating FDA website navigation. Among the many uses, newsletters are used to objectively evaluate risk, prioritize audit observations and corrective actions, prepare for internal audits and as training tools in addition to defining regulatory.
