Friday, February 28, 2014

Internet Pharmacies: Most Rogue Sites Operate from Abroad, and Many Sell Counterfeit Drugs - U.S. GAO

Updated Feb 1, 2016:
You might have also been looking for:
NABP/AwareRx List of Not Recommended Sites

- -  original post follows below - -

U.S. GAO - Internet Pharmacies: Most Rogue Sites Operate from Abroad, and Many Sell Counterfeit Drugs:

"Although the exact number of rogue Internet pharmacies is unknown, one estimate suggests that there were over 36,000 in operation as of February 2014, and these rogue sites violate a variety of federal laws. Most operate from abroad, and many illegally ship prescription drugs into the United States that have not been approved by the Food and Drug Administration (FDA), including drugs that are counterfeit or are otherwise substandard. Many also illegally sell prescription drugs without a prescription that meets federal and state requirements. Foreign rogue Internet pharmacies use sophisticated methods to evade scrutiny by customs officials and smuggle drugs into the country. Their operators also often violate other laws, including those related to fraud and money laundering."

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Thursday, February 27, 2014

Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR

My medical instrument
My medical instrument (Photo credit: Wikipedia)
Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR:

"But while there are guidelines that recommend that all doctors wash their hands before and after visiting each patient, there are none mandating that small medical equipment like stethoscopes should also be disinfected after every single use."

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Monday, February 24, 2014

Executive Session - Advanced GMP Training

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Executive Session is an advanced course that addresses CGMP & QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

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Avoid Retail Clinics for Pediatric Care, AAP Says - Medscape

Avoid Retail Clinics for Pediatric Care, AAP Says: (Medscape):

"Although in-store medical clinics have been proliferating since they first appeared in 2000, most medical societies and many physicians think they are a bad idea.

Firmly in that camp is the American Academy of Pediatrics (AAP), which renewed its opposition to retail-based clinics (RBCs) in a policy statement published online February 24 in Pediatrics.

The growth of RBCs has been significant, with such clinics numbering 6000 as of 2012, according to the AAP statement. In previous surveys, about 15% of respondents anticipated that in the future they would likely be using in-store clinics for at least part of their children's medical care. (Most people treated at in-store clinics are adults.)"

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Friday, February 21, 2014

Root Cause Investigations Workshop - cGMP Training

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Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

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Thursday, February 20, 2014

Drug Supply Chain Security Act - Drug Supply Chain Security Act (DSCSA) Implementation Plan

Follow the link below to view the graphic . . .

Drug Supply Chain Security Act > Drug Supply Chain Security Act (DSCSA) Implementation Plan:

"Drug Supply Chain Security Act (DSCSA) Implementation Plan. The following graphic represents a summary of planned implementation timeframes for the Drug Supply Chain Security Act over a 10-year period. Timeframes are estimates and are based on the requirements set forth in the law. This implementation plan will be updated as appropriate"

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Wednesday, February 19, 2014

Healthcare organizations under siege from cyberattacks, study says - latimes.com

Healthcare organizations under siege from cyberattacks, study says - latimes.com:

"The study was conducted by Norse, a Silicon Valley cybersecurity firm, and SANS, a security research institute. In the report, the groups found from September 2012 to October 2013 that 375 healthcare organizations in the U.S. had been compromised, and in many cases are still compromised because they have not yet detected the attacks.  In addition to getting access to patient files and information, the attackers managed to infiltrate devices such as radiology imaging software, conferencing systems, printers, firewalls, Web cameras and mail servers."

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Monday, February 10, 2014

GMP Training - Olympic-Style

  • Do your employees avoid CGMP training, claiming they've heard it all? 
  • Do they resist attending CGMP training because "their" job is never discussed? 
  • Do some employees "drift off" in CGMP training because it is too theoretical? 
If you answered "Yes" to any of these questions, then you need to take a look at our GMP Olympics Refresher course.

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This course can be customized to meet a variety of content and time constraints.

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Allan Dewes
Allan Dewes, President.
About Your Instructor
Allan Dewes
  
Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.

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Hackers break into networks of 3 big medical device makers - SFGate

Hackers break into networks of 3 big medical device makers - SFGate:

"Hackers have penetrated the computer networks of the country's top medical device makers, The Chronicle has learned.

The attacks struck Medtronic, the world's largest medical device maker, Boston Scientific and St. Jude Medical sometime during the first half of 2013 and might have lasted as long as several months, according to a source close to the companies.

It's not clear what exactly the hackers were after, but federal laws meant to safeguard medical information require the companies to disclose any breach involving patient information. The companies have made no such disclosures."

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Saturday, February 8, 2014

FDA Sets Standards for Infant Formula

Constituent Updates > FDA Sets Standards for Infant Formula:

"FDA is also publishing two draft guidance documents to provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature and have special dietary needs; this type of formula is not the subject of the interim final rule. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule."

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Additional Information: 

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Thursday, February 6, 2014

Do You Have SOP Compliance Problems?

#FDA #GMP #cGMP #QSR #training #course
  • Do CGMP documents contain many errors, or
  • Are change controls often side-stepped, or 
  • Is the Quality Unit often side-stepped, or 
  • Are procedures not always followed?
If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

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Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:
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  2. Procedures not being followed
  3. Change control not practiced
  4. QA not consulted on deviations 
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About Your Instructor
Allan Dewes

Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.

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Wednesday, February 5, 2014

Didn't get a flu vaccine yet? It's still not too late - US FDA | Facebook

Didn't get a flu vaccine yet? It's still... - U.S. Food and Drug Administration | Facebook:

"Didn't get a flu vaccine yet? It's still not too late. Flu activity usually peaks in January or February, and can last well into May. According to the CDC, this flu season strain seems to be hitting young and middle-aged adults particularly hard."

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cGMP/QSR Trainer Certification Public Seminar by SkillsPlus International Inc. - May 5-9, 2014
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Tuesday, February 4, 2014

The FDA conducted 39,774 inspections in 2013 | FDAzilla Blog

The FDA conducted 39,774 inspections in 2013 | FDAzilla Blog:

"The FDA ended 2013 with 39,774 inspections – a 5-year low.  It’s the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522)."

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2014 Vaccine Recommendations - Adult Immunization Schedules and Tools for Providers - CDC

English: Logo of the Centers for Disease Contr...
English: Logo of the Centers for Disease Control and Prevention, an agency within the United States Department of Health and Human Services. White on blue background with white rays but no white "burst". No detailed wording. (Photo credit: Wikipedia)
CDC - Vaccines - Adult Immunization Schedules and Tools for Providers:

"Each year, the Advisory Committee on Immunization Practices (ACIP) reviews the recommended adult (anyone over 18 years old) immunization schedule to ensure that the schedule reflects current recommendations for the licensed vaccines."

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Once Again, Lack of SOP Compliance Tops List of 483 Observations - BioProcess Blog

BioProcess Blog » Blog Archive » Once Again, Lack of SOP Compliance Tops List of 483 Observations:

"Top of the FDA list, at 155 of the 690 citations (22%) was the observation that “The responsibilities and procedures applicable to the quality control unit are not in writing or not fully followed.” This finding emphasizes the importance that the regulatory agencies have always placed on the need for companies to have strong quality management systems."

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GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL

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