QC/QA analyst needed

Manufacturing Team Leaders needed.

Manufacturing Technicians needed

Manufacturing Formulation Team Leader needed

I am writing a document on management. I would like to have each of you as part of my research. Obviously this is a wide demographic. I am looking for answers and narratives to certain questions and philosophies. You may answer any or all of the questions. You may also impart some of your insightful knowledge. I would also gladly take any other observations or stories about a great boss or an awful one.
I would take responses as a mailed attachment if this is easier. Cut and paste the questions into a word file.
These are intended as a narrative to get a feel on how people interpret and perceive management.
I also am posting a more rigid survey on my website.

How would you describe a good managers approach to a difficult situation, i.e. we have to work Christmas? You have to work Christmas?

How often do you receive feed back from your boss on performance?
Do you receive clear written goals?
What is the best thing a company has ever done for you? How did your manager influence this?
What is the worst thing (not precipitated by poor performance) a company has done. How did your manager influence this?

What makes you feel like your boss understands you?
What invests you in the company?
What instills loyalty to your boss?
How soon after you receive a pay increase do you forget about it?
How would you handle a situation where you perceived your boss was playing favorites?

My talent is valued at work?
Describe a manager with excellent communication skills.
What is the most important trait in a boss?
What is the best way a boss can impart bad news? i.e. no raises?
What is the worst trait in a boss?

You may complete this and email it back or mail it. Soon it will be interactive where you just click your selection.
Thank you to anyone who participates. The survey will take a full year to compile.
natp93@comcast.net
69 Harvard Ave Medford, Ma 02155

I am writing a document on management. I would like to have each of you as part of my research. Obviously this is a wide demographic. I am looking for answers and narratives to certain questions and philosophies. You may answer any or all of the questions. You may also impart some of your insightful knowledge. I would also gladly take any other observations or stories about a great boss or an awful one.
I would take responses as a mailed attachment if this is easier. Cut and paste the questions into a word file.
These are intended as a narrative to get a feel on how people interpret and perceive management.
I also am posting a more rigid survey on my website.

How would you describe a good managers approach to a difficult situation, i.e. we have to work Christmas? You have to work Christmas?

How often do you receive feed back from your boss on performance?
Do you receive clear written goals?
What is the best thing a company has ever done for you? How did your manager influence this?
What is the worst thing (not precipitated by poor performance) a company has done. How did your manager influence this?

What makes you feel like your boss understands you?
What invests you in the company?
What instills loyalty to your boss?
How soon after you receive a pay increase do you forget about it?
How would you handle a situation where you perceived your boss was playing favorites?

My talent is valued at work?
Describe a manager with excellent communication skills.
What is the most important trait in a boss?
What is the best way a boss can impart bad news? i.e. no raises?
What is the worst trait in a boss?

You may complete this and email it back or mail it. Soon it will be interactive where you just click your selection.
Thank you to anyone who participates. The survey will take a full year to compile.
natp93@comcast.net
69 Harvard Ave Medford, Ma 02155

Fabry’s disease is a rare genetics disorder that is fatal. Treated people live relatively normal lives. More posts are to come.

Join World Run Day for Fabry Disease Join the National Fabry Disease Foundation to participate in and to support World Run Day to help people the rare genetic disorder Fabry disease to live better and longer lives! World Run Day is November 7, 2010 What is World Run Day? World Run Day was founded to celebrate the sport of running worldwide. Its mission is to broaden and promote the health benefits of running while also encouraging runners to donate to their own favorite charity on this special day. It is a very special international day of running and charitable giving. Runners all over the world participate in local running events in groups or individually in organized running events in various cities or on their own chosen courses. We are encouraging support to the National Fabry Disease Foundation on World Run Day to help us to provide critical physician and family education programs to increase recognition and diagnoses of our severely under-recognized disease, and to provide support and assistance to families with Fabry disease in need. To participate as an individual go to www.runday.com and select “Click here to Register” at the top center of the page. To register as a group select the GROUP EVENT DISCOUNT LINK.

Thw world run day which included the run for lysosomal disorders and Fabry disease occured on November 7th. The event raised a mere $395 dollars for Fabry’s. Next eyar this will need to improve.  I will be working to get various groups involved including my church for 2011.

In a  world where drugs from foreign countries are suspect Americans should still be wary of domestic pharmaceutical companies. 

Companies still exist that still ignore regulations and adulterate drugs. The bottom line  and earnings for some companies is the determining factor when manufacturing drugs. Some executives directors use intimidation to ensure compliance risks are ignored. Humiliation is often a common tactic used.

Employees are often discouraged from identifying issues.  Employees are intimidated, and are subjected to punitive reactions.

FDA warns Braintree Laboratories about bugs in its laxatives

By Brian Benson

The Patriot Ledger

Posted May 19, 2010 @ 07:34 PM

Last update May 20, 2010 @ 08:31 AM

The Food and Drug Administration has issued a second warning to Braintree Laboratories after insects were discovered in some of its products.

The FDA received 21 complaints from consumers who found insects, insect parts and spiders in five products made by the Braintree-based company at its Holbrook manufacturing facility, according to a May 10 letter to the company from John R. Marzilli, district director for the New England District of the FDA in Stoneham.

FDA investigations in December and January identified significant violations of Current Good Manufacturing Practice regulations at the pharmaceutical company, which makes gastrointestional drugs including the laxative MiraLax.

Braintree Laboratories failed to determine if “facility or raw material quality problems were at the root of these complaints,” Marzilli wrote.

The company previously told the FDA it would increase pest control monitoring, look for trends among complaints and determine the origin of the insects.

But, the FDA also wants Braintree Laboratories to submit a plan for determining additional potential contamination sources and audit its raw materials and packaging suppliers.

“FDA considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue,” Marzilli wrote.

Officials from Braintree Laboratories were unavailable for comment Wednesday, a company operator said.

The company has 15 working days upon receipt of the letter to tell the FDA what they are doing to correct the violations or seek an extension. If they fail to act, Braintree Laboratories could face product seizure, injunctions, or withholding of future product approval requests.

FDA officials examine each situation on a case-by-case basis to determine what penalties are imposed, said Mary Yebba, public affairs specialist for the FDA’s New England District.

Brian Benson may be reached at bbenson@ledger.com.

Copyright 2010 The Patriot Ledger. Some rights reserved

Think about where you travel. The earth has become smaller. As technoloogy improves and the business world opens up new opportunities, the movement of people and material becomes routine. Because it is routine, the monitoring and prevention of foreign species of plants and animals has become a liability. With the destruction of physical and natural boundaries, the introduction of “things” that put us in harms was has become pervasive. The newest transplants are viruses and bacteria. Even with the most advanced pharmaceutical development capability and top notch health care, our health and lives are being threatened.

A new superbug could spread around the world after reaching Britain from India — in part because of medical tourism — and scientists say there are almost no drugs to treat it.

Researchers said on Wednesday they had found a new gene called New Delhi metallo-beta-lactamase, or NDM-1, in patients in South Asia and in Britain.

NDM-1 makes bacteria highly resistant to almost all antibiotics, including the most powerful class called carbapenems, and experts say there are no new drugs on the horizon to tackle it.

With international travel in search of cheaper healthcare increasing, particularly for procedures such as cosmetic surgery, Timothy Walsh, who led the study, said he feared the new superbug could soon spread across the globe.

“At a global level, this is a real concern,” Walsh, from Britain’s Cardiff University, said in telephone interview.

“Because of medical tourism and international travel in general, resistance to these types of bacteria has the potential to spread around the world very, very quickly. And there is nothing in the (drug development) pipeline to tackle it.”

Almost as soon as the first antibiotic penicillin was introduced in the 1940s, bacteria began to develop resistance to its effects, prompting researchers to develop many new generations of antibiotics.

But their overuse and misuse have helped fuel the rise of drug-resistant “superbug” infections like methicillin-resistant Staphyloccus aureus (MRSA).

In a study published in The Lancet Infectious Diseases journal on Wednesday, Walsh’s team found that NDM-1 is becoming more common in Bangladesh, India, and Pakistan and is also being imported back to Britain in patients returning after treatment.

“India also provides cosmetic surgery for other Europeans and Americans, and it is likely NDM-1 will spread worldwide,” the scientists wrote in the study.

For many years, antibiotic research has been a “Cinderella” sector of the pharmaceuticals industry, reflecting a mismatch between the scientific difficulty of finding treatments and the modest sales such products are likely to generate, since new drugs are typically saved only for the sickest patients.

But the increasing threat from superbugs is encouraging a rethink at the few large drugmakers still actively hunting for new antibiotics, including Pfizer, Merck, AstraZeneca, GlaxoSmithKline and Novartis.

Walsh and his international team collected bacteria samples from hospital patients in two places in India, Chennai and Haryana, and from patients referred to Britain’s national reference laboratory between 2007 and 2009.

They found 44 NDM-1-positive bacteria in Chennai, 26 in Haryana, 37 in Britain, and 73 in other sites in Bangladesh, India, and Pakistan. Several of the British NDM-1 positive patients had recently traveled to India or Pakistan for hospital treatment, including cosmetic surgery, they said.

Most worryingly, NDM-1-producing bacteria are resistant to many antibiotics including carbapenems, the scientists said, a class of the drugs often reserved for emergency use and to treat infections caused by other multi-resistant bugs like MRSA and C-Difficile.

Anders Ekblom, global head of medicines development at AstraZeneca, whose Merrem antibiotic is the leading carbapenem, said he saw “great value” in investing in new antibiotics.

“We’ve long recognized the growing need for new antibiotics, he said. “Bacteria are continually developing resistance to our arsenal of antibiotics and NDM1 is just the latest example.”

Experts commenting on Walsh’s findings said it was important to be alert to the new bug and start screening for it early.

“If this emerging public health threat is ignored, sooner or later the medical community could be confronted with carbapenem-resistant (bacteria) that cause common infections, resulting in treatment failures with substantial increases in health-care costs,” Johann Pitout from the University of Calgary in Canada wrote in a commentary in same journal.

Colonoscopy- 10 informative points every patient will need to know (Ny Times)

Poopy and mucosal

Ready for inspection

Colorectal cancer is the second leading cause of cancer death in the United States, it affects both men and women and it almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible during the popular screening test known as colonoscopy.(click here). You may also view a more comprehensive video of the procedure and information regarding this and other medical topics on my site under the training tab (click here).

Can the FDA streamline the approval process and deliver medicines to patients? (click here) Washington Post.

Welcome to a site dedicated to pharmaceutical management issues; cGMP, Safety, OSHA, EPA, DOT and personell management topics. The site contains tabs for relevent educational information, safety information, powerpoint presentations, local news and events.