The FDA Inspection Process; Tips and strategy
The FDA is always looking for entry points into your documentation to highlight potential issues...
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by Nigel J Smart PhD | Jan 12, 2020 | Announcements | 0 |
The FDA is always looking for entry points into your documentation to highlight potential issues...
Read Moreby Nigel J Smart PhD | Mar 10, 2011 | Announcements | 0 |
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 Moreby Nigel J Smart PhD | Sep 26, 2010 | Announcements, White Papers | 0 |
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 Moreby Nigel J Smart PhD | Jun 28, 2010 | Announcements, Articles | 0 |
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 Moreby Nigel J Smart PhD | Jun 28, 2010 | Announcements | 0 |
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 Moreby Nigel J Smart PhD | Jun 25, 2010 | Announcements, Articles | 0 |
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 Moreby Nigel J Smart PhD | Jun 25, 2010 | Announcements, Articles | 0 |
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 Moreby Nigel J Smart PhD | Jun 22, 2010 | Announcements, Articles | 0 |
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 Moreby Nigel J Smart PhD | Jun 18, 2010 | Announcements | 0 |
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 Moreby Nigel J Smart PhD | Jun 11, 2010 | Announcements, Articles | 0 |
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 Moreby Nigel J Smart PhD | Jun 10, 2010 | Announcements, Articles | 0 |
Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company’s bottom line. Nevertheless, the ROI can be significant with solutions that automate routine and...
Read Moreby Nigel J Smart PhD | Jun 7, 2010 | Announcements | 0 |
In April 2010, an important number of the world’s top experts in pediatric pharmacogenomics and personalized medicine came together at a unique conference to change the way childhood diseases are treated. The conference...
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Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.