Wednesday, May 22, 2019

SkillsPlus International Inc. Announces Online GMP e-Learning Courses

SkillsPlus International Inc. proudly announces  the reintroduction and updating of our very popular GMP e-learning courses. 
FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Training Courses by SkillsPlus Intl Inc.


Do you need . . . ?

  • New employee GMP training awareness that is quick and easy?
  • Annual refresher training that is on a flexible schedule for team members?
  • Training solutions that are responsive to a demanding production environment?

Our LMS GMP Training solution is the answer to your needs!

  • A current list of topics is available.
  • 24-7 Availability
  • An ever growing list of topics is planned.
  • Our pricing is structured for today’s tight budgets

Additional Features

  • Private classrooms allow your company trainer to share notes to all your employees.
  • Trainers can be identified as classroom monitors to tracking student grades and completion.

Online Courses Currently Available - and view the details

  • 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
  • Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
  • Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
  • Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
  • Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
  • Plan to Production - Part F. Review the requirements for production process controls and validation.
  • Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
  • Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
  • Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

Email us for a quote:  skillsplus@aol.com

Saturday, May 18, 2019

The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

Read the full article:  The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

"Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results."


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Tuesday, April 9, 2019

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

Read the full press release:

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

The U.S. Food and Drug Administration . . .

"approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 
“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”"


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#FDA

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thursday, February 28, 2019

FDA plans first public hearings on legalizing CBD foods in April - CNBC

Read the full article:  FDA plans first public hearings on legalizing CBD foods in April - CNBC

"The Food and Drug Administration will hold its first public hearings on CBD in April as the agency weighs rules allowing companies to add the popular cannabis-based compound to food, Commissioner Scott Gottlieb said Wednesday. 
"We're deeply focused on this. We have taken on other hard challenges before," Gottlieb told the House Appropriations Committee on Wednesday. "You have my commitment I'm focused on this one.""

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, February 8, 2019

Liquor before beer? You will still feel terrible, new study says - CNBC

Wine Lovers Dishwasher Magnet - Clean or Dirty
Wine Lovers Dishwasher Magnet - Clean or Dirty

Read the full article:  Liquor before beer? You will still feel terrible, new study says - CNBC

"... a new medical study has concluded that the threat of a crushing hangover cannot be removed by making sure that beer comes before, or after, wine. 
The study, published in the American Journal of Clinical Nutrition on Friday, went further claiming that hangovers were also not made more bearable by sticking to one type of drink thereby debunking another of the barfly's favorite: "Grape or grain but never the twain.""


SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

From SkillsPlus International Inc.