Showing posts with label resources. Show all posts
Showing posts with label resources. Show all posts

Saturday, February 21, 2015

The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS


Explore the entire list of links: The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS:

"Regulatory Focus has assembled this list of the most important FDA webpages, government websites and non-governmental websites, all in the hopes of making FDA-related information easier to find.

This page is intended to assist anyone interested in FDA, including regulatory professionals, journalists, academics, patients, healthcare providers and stock traders."

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Wednesday, July 16, 2014

U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg

Read the full article: U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg:

"In a letter calling for a “new sense of economic patriotism,” Treasury Secretary Jacob J. Lew said Congress should approve tax changes retroactive to May.

“We should prevent companies from effectively renouncing their citizenship to get out of paying taxes,” Lew wrote in the letter to top congressional tax writers, which was dated yesterday and obtained by Bloomberg News. “We should not be providing support for corporations that seek to shift their profits overseas to avoid paying their fair share of taxes.”

The mergers used to legally avoid taxes, known as inversion transactions, have become increasingly popular over the past year, particularly in the pharmaceutical industry. "

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Wednesday, June 25, 2014

Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances


Follow the link below to a webpage that contains links to the 3 final guidances.

Read the full article: Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances - FDA.gov:

"In June 2014, FDA issued three final guidance documents reflecting FDA’s current thinking on certain issues related to the use of nanotechnology in FDA-regulated products. FDA prepared these final guidances after taking into account public comment received on the corresponding draft guidance documents previously issued in 2011 and 2012. These guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report."

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Monday, June 23, 2014

Pure Food and Drug Act passes in Congress, June 23, 1906 - POLITICO.com

English: Theodore Roosevelt, circa 1902
English: Theodore Roosevelt, circa 1902 (Photo credit: Wikipedia)
Read the full article: Pure Food and Drug Act passes in Congress, June 23, 1906 - Andrew Glass - POLITICO.com:

"On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams."

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Friday, May 16, 2014

Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

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Monday, May 12, 2014

17 Awesome Resources on Micro-Learning - eLearning Industry

17 Awesome Resources on Micro-Learning - eLearning Industry:

"Micro learning is learning in small steps (contrary to the traditional approach of learning through hour-long courses). It is made possible with the aid of small, well planned, bite-sized chunks of units or activities (also called learning nuggets) that are short-term, digestible, and easily manageable. ...

Micro learning is going to be the future of learning. It is all set to transform how we learn both for our personal as well as our professional needs. We foresee micro learning tools evolving into an essential component of any enterprise learning toolbox. "

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Wednesday, July 17, 2013

Designated Representative Training | Education


Training Program For California Designated Representative License Applicants


SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

California requires drug and device wholesalers to retain a CA-licensed pharmacist or Designated Representative, on-site, to conduct their business. The pharmacist or Designated Representative must be physically present during all hours of operation.

Florida requires Designated Representatives working at drug and device wholesalers to be trained in specific Florida pharmacy laws.

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Follow this link, to learn more about pharmacy Designated Representative training, on the Designated Representative Institute website

Note:
In CA, the pharmacy Designated Representative was formerly called the Exemptee.

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California Designated Representative Training Courses - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses - Approved by the California State Board of Pharmacy - Earn a training affidavit




Thursday, November 29, 2012

GHTF Archives Can Be Found On The IMDRF Website

"The Global Harmonization Task Force (GHTF), the global medical device harmonization body no longer exists. The GHTF has been permanently replaced by the IMDRF (International Medical Device Regulators Forum), a successor organization comprised of officials from regulatory agencies around the world. The GHTF website no longer exists. Fortunately, the GHTF Archives are now housed on the IMDRF website. These archives (follow the hyperlink below) should be considered historic information, no longer current, and therefore, should not be acted upon.

http://www.imdrf.org/ghtf/ghtf-archives.asp "

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Saturday, December 31, 2011

Don't Get Caught Without A California HMDR Exemptee

We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. 

Avoid jeopardizing your business.

  • Don't get caught without a California Department of Public Health (CDPH) Home Medical Device Retailer (HMDR) Exemptee.
  • It's a wise investment to have more than just one Exemptee, so that you have additional Exemptees for backup and cross-covering.
  • The cost of training another Exemptee is very reasonable, in contrast to having to close down the business.
Here's a free tip:
One of many minimum qualifications to become a California HMDR Exemptee is work experience. Applicants must have one or more years paid experience. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent. No exceptions!

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Training program for California Home Medical Device Retailer (HMDR) license applicants
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around



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