Showing posts with label courses. Show all posts
Showing posts with label courses. Show all posts

Wednesday, June 29, 2022

SkillsPlus International Inc. - The leader in compliance training

Image of the SkillsPlus International Inc. logo

SkillsPlus International Inc.

The leader in compliance training

Specializing in:
  • FDA cGMP online training programs and courses
  • California Designated Representative training courses for license applicants
  • California HMDR Exemptee training certification for license applicants

Mailing Address

SkillsPlus International Inc.
1183 University Drive Ste 105-251
Burlington, NC
27215
USA

Thursday, February 17, 2022

The FDA’s Cigarette Health Warning Rule Is Postponed to April 2023

U.S. Graphic Health Warnings Postponed Again


According to the article:

Source: FDA.gov
"The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022."

Read the full source article:  U.S. Graphic Health Warnings Postponed Again - Tobacco Reporter

Learn more at: Cigarette Labeling and Health Warning Requirements - FDA.gov

Keywords & Phrases:
#FDA #CGMP #GMP


Friday, January 7, 2022

Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

According to the FDA:

"Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants.

Injectable skin whitening products are marketed for injection into a vein or muscle or under the skin. They are sold online and in some retail outlets and health spas. They often promise to lighten the skin, correct uneven skin tone, and reduce blemishes. Some products even claim to treat conditions such as liver disorders and Parkinson’s disease.

Although the average consumer might not assume so, these products are unapproved new drugs whose sales are not condoned by the U.S. Food and Drug Administration (FDA). The FDA has not approved any injectable drugs for skin whitening or lightening."

Source:  Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

Wednesday, December 22, 2021

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

According to the article:

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset."

Read the full source article: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov


Thursday, April 1, 2021

California Designated Representative 3PL Training Course

California Designated Representative 3PL Training Course

Intended for California Designated Representative 3PL license applicants and their supervisors.
$525 per student - Buy now! - California Designated Representative 3PL Training Course

  • If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.
  • Approved by the California State Board of Pharmacy. Covers all the required topics specified by the license application form.
  • Online training classroom available 24 x 7
  • More than 7,000 students have taken our state license-related courses

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California Designated Representative 3PL Training Course. California 3PL Designated Representative Training Course. Image of a glowing blue laptop in the darkness.
California Designated Representative 3PL Training Course

Wednesday, March 10, 2021

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Training Courses

Current Good Manufacturing Practice Training: A New Generation Series 
In 8 one-hour segments, learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing.


If you are visiting here, ask yourself these three questions:

  • Do you need to conduct CGMP Training on a limited budget? 
  • Do you want employees to learn the CGMPs from an expert using real examples? 
  • Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

  • 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.

Current Good Manufacturing Practice Training: A New Generation Series  In 8 one-hour segments, learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. Image of gloved hand holding a flask.
Current Good Manufacturing Practice Training: A New Generation Series - GMP Online Training Courses

Take action today!

Tuesday, January 12, 2021

First rapid concussion blood test approved by FDA - WGN News (video)

Source YouTube Video:  First rapid concussion blood test approved by FDA - WGN News (video)

Monday, December 28, 2020

FDA sends CBD warning letters to five companies - Food Business News

According to the article:

"The US Food and Drug Administration on Dec. 22 issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The five companies illegally were marketing unapproved CBD products claiming to treat medical conditions, according to the FDA."

Read the full source article:   FDA sends CBD warning letters to five companies - Food Business News

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Free GMP Training Tips

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 

Saturday, December 19, 2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older."

Read the full news release:  FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

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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 

Wednesday, December 16, 2020

FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov


Wednesday, November 18, 2020

FDA Is Hosting A Conference On CBD, Sex And Gender This Week - Marijuana Moment

Read the full source article:  FDA Is Hosting A Conference On CBD, Sex And Gender This Week - Marijuana Moment

According to the article ...

"As the federal government continues to develop regulations around CBD, the Food and Drug Administration (FDA) will host a public conference on Thursday to highlight how the cannabinoid’s use and effects may differ based on sex and gender.

The daylong meeting, organized by FDA’s Office of Women’s Health, will include presentations on “sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation,” according to an agency description."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog


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 

Saturday, September 26, 2020

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

Updated April 11, 2024

The original link broke.

You might also be interested in:

---  the original post follows below  --

Read the full FDA Safety Communication:  
Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

According to the communication:

"The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include:
  • Pregnant women and their developing fetuses;
  • Women who are planning to become pregnant;
  • Nursing women and their newborns and infants;
  • Children, especially those younger than six years of age;
  • People with pre-existing neurological disease;
  • People with impaired kidney function; and
  • People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam."

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FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.


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, August 21, 2020

FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

According to the update:

"To assist the food industry as it navigates changes to operations related to COVID-19, the FDA has teamed up with OSHA to develop the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic.” The checklist pulls from existing guidance provided by the FDA, CDC, and OSHA and serves as a quick reference to help the food industry assess employee health, social distancing, and food safety within workplaces as operations may be impacted by COVID-19. 

The checklist is broken into two distinct sections. The first section focuses on employee health, screening, and operation configuration for social distancing to prevent or minimize the spread of COVID-19 based on guidelines provided by CDC and OSHA. The second section highlights food safety requirements, found in existing regulations, that can help the food industry assess the potential impact of COVID-19-related operational changes on food safety practices. Some operational changes that could impact food safety include closures, changes among food safety staff, or changes to suppliers or ingredients."

Read the full source article: 
FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

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FDA cGMP QSR GMP Training Courses - online classes by SkillsPlus International Inc.


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, July 30, 2020

FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

Read the full news release:  FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

According to the article:

... "the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC."

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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, March 6, 2020

FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity - FDA.gov

According to the FDA Statement:
"Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity."
Read the full FDA Statement:  FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity - FDA.gov

You might also be interested in:
FDA Finally Sends Overdue CBD Enforcement Update To Congress - Marijuana Moment

According to the Marijuana Moment article:
"While the process remains ongoing, the agency announced that it is actively exploring pathways to allow for the marketing of cannabidiol as a dietary supplement and is developing enforcement discretion guidance. It will also be reopening a public docket to solicit additional scientific information about the risk and benefits of the cannabis compound."
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

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 

Wednesday, February 19, 2020

FDA cGMP Training - online training courses by SkillsPlus International Inc.

FDA GMP Training - online training classes by SkillsPlus Intl Inc.
FDA GMP Training - online training classes by SkillsPlus Intl Inc.

Benefits

  • Use in the classroom as a training video
  • Standardize content delivery
  • Reduce training expense with our online learning pricing
  • Use in one-on-one training environments
  • Make these classes a part of corrective and preventive actions 

Details

  • $50 per individual course 
  • Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
  • Call us about Annual Global License pricing.
  • Interested in a course? Give us a call:  (415) 948-5220

Courses Available

  • 21 CFR 211: Pure, Safe, and Effective  - This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
  • Documentation Practices  - This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments. 
  • Equipment and CGMPs - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

Saturday, December 28, 2019

Retail Sales of Tobacco Products - FDA.gov

Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note:
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

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FDA cGMP QSR GMP online training courses by SkillsPlus Intl Inc.
FDA cGMP QSR GMP online training courses by SkillsPlus Intl Inc.


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 

Wednesday, December 18, 2019

FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.


FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.


FDA cGMP QSR GMP Online Training

Benefits

  • Use in the classroom as a training video
  • Standardize content delivery
  • Reduce training expense with our online learning pricing
  • Use in one-on-one training environments
  • Make these classes a part of corrective and preventive actions 

Details

  • $50 per individual course 
  • Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
  • Call us about Annual Global License pricing.

  • Interested in a course? Give us a call:  (415) 948-5220

Courses Available

  • 21 CFR 211: Pure, Safe and Effective - Subparts A-K  
  • Your Personal Responsibilities - Subpart B  
  • Foundation to Facilities - Subpart C  
  • Maintaining Compliant Equipment Practices - Subpart D  
  • Supplier to Plant - Subpart E
  • Plant to Production - Subpart F
  • Plant to Patient - Subpart G, H, & K
  • Laboratory to Release - Subpart I
  • Proper Documentation Practices - Subpart J

From SkillsPlus International Inc.