Poll: Public wants strong medical device oversight:
" . . . 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.
Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law."
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Tuesday, March 20, 2012
Public wants strong medical device oversight
Sunday, March 18, 2012
What Stresses Some Pharma Employees The Most
An interesting report of stresses on pharma, and the stresses that pharma employees experience.
What Stresses Some Pharma Employees The Most // Pharmalot:
" . . . when asked about the biggest changes at work, nearly half say that on-the-job conditions are worse - 49.5 percent cited increased workloads due to staff cuts and nearly 49 percent report a new team or organizational structure. Nearly 18 percent say they are burnt out most of the time and 55.4 percent are burnt out some of the time. Almost 39 percent complain this is a real issue that is hurting productivity. And 45 percent say they have to pitch in to do things outside their domain.
Interestingly, when asked how the economy has hurt their employer recently, the responses indicated some improvement - nearly 38 percent report a hiring freeze, down from nearly 50 percent the year before. Similarly, 41 percent named layoffs, compared with 53 percent in the prior year. Salary freezes were cited by 19.4 percent versus 29.2 percent, and 24.7 percent pointed to outsourcing, down from 33.8 percent."
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Tuesday, March 13, 2012
Using Video In The Classroom - Free GMP and QSR Training Tip
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- "Tell the class what they are going to see and why you want them to see it.
- Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD."
- Now it's time to turn on the DVD. See our list of SkillsPlus Intl Inc. movies and interactive CBTs
- After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate."
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- Using Video In The Classroom - Free GMP and QSR Training Tip (skillsplusinfo.blogspot.com)
Sunday, March 11, 2012
FDA rethinking food inspections
I wonder what Upton Sinclair would say about the state of current affairs.
FDA rethinking food inspections - DailyHerald.com:
"The surge in imports has also increased the chances of contamination in foods regulated by the FDA. About 80 percent of seafood, 50 percent of fresh fruits and 20 percent of fresh vegetables are imported.
Despite the mounting threats, the FDA and its contractors inspected only 6 percent of the 421,000 domestic and foreign facilities under its watch in 2010, according to the most recent figures. Inspections account for the full-time work of just 1,000 employees. But if a site is linked to an outbreak of illness, inspectors and FDA scientists descend on it, sometimes staying put for weeks.
Under the food-safety bill enacted last year, food companies must adopt plans to spot and prevent hazards. The law also mandates more frequent inspections. For instance, plants that produce or process high-risk foods, including foods connected to previous outbreaks, must be inspected by 2015 and every three years thereafter."
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- FDA Audit Preparation (drughealth.blogspot.com)
Knock, Knock, FDA Calling
This is a nice article with a nutritional supplement twist to it.
Knock, Knock, FDA Calling - Slowtwitch.com:
"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."'via Blog this'
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