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...
Read MoreThe Secret to Tissue Regeneration… In The Body of a Worm?
Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated, and we’re talking about even its whole head and brain! The...
Read MoreHow to Perform a Mock Audit
After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria...
Read MoreThe Secret to Tissue Regeneration… In The Body of a Worm?
Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The...
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