Category: Announcements
The FDA Inspection Process; Tips and strategy
The FDA is always looking for entry points into your documentation to highlight potential issues...
Read MoreNew Data on the Inspection of Human Cell & Tissue Products by the FDA
A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of...
Read MoreInnovative R&D Through Lean Manufacturing Principles
The term “lean manufacturing” was first coined by James Womack, a professor at MIT, in his 1990 book titled The Machine that Changed the World. Lean manufacturing techniques have gained a growing number of advocates...
Read MoreThe Future of Regenerative Medicine
Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with...
Read MoreFDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake
Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is...
Read MoreDiabetes Trends Until 2025
Diabetes is a chronic metabolic disorder that develops because the body is not able to produce the hormone insulin and/or is unable to respond effectively to the insulin that is produced. There are two types of diabetes: -Type...
Read MorePharma Sales Reps Facing a Hostile World
The medical world is showing its ugly, hostile face to pharma sales reps. The number of doctors that are willing to meet with pharma sales reps on a regular basis is dropping alarmingly, and the group that doesn’t want to...
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