Wednesday, October 21, 2020

Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

Read the full source article:  Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

According to the article:

"Commercials for Prevagen have insisted that “it’s safe and effective,” an assurance Quincy echoed to regulators. But an investigation by WIRED now shows that for years officials at the FDA questioned the basis for the company’s claims. Multiple FDA inspections, most of which have not been reported before, found significant issues with Quincy’s manufacturing processes, complaint handling, and the quality control testing that was supposed to ensure its products were safe.

And thousands of Americans have reported experiencing “adverse events” while taking Prevagen, including seizures, strokes, heart arrhythmias, chest pain, and dizziness. While the existence of adverse event reports alone don’t prove a product is the cause, the nature and pattern of complaints about Prevagen worried FDA officials, according to agency records. One internal report from 2015 stated that the “numerous adverse events reported” indicated “a serious safety hazard.” "

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

Monday, September 28, 2020

FAQ: What is a California Designated Representative training affidavit?


According to the article:

"The training affidavit is proof of required training.

In general, individuals applying for a designated representative license in California must submit proof that they have completed required training as specified on their applicable license application Training Affidavit form."

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California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. -  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

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Saturday, September 26, 2020

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

Read the full FDA Safety Communication:  

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
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The Designated Rep and Exemptee Professionals Blog
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
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Friday, September 4, 2020

FAQ: Where can I find California Board of Pharmacy Designated Representative training courses?

Here's the answer to the FAQ:  Where can I find California Board of Pharmacy Designated Representative training?

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California Board of Pharmacy Designated Representative Training Courses (by SkillsPlus International Inc.)


SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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The Designated Rep and Exemptee Professionals Blog
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, September 3, 2020

Prescription deliveries: Health care providers urge patients to be proactive as COVID pandemic, USPS troubles cause delays - USA Today

 According to the news article:

"But as a surge in deliveries strain the postal system and the Trump Administration opposes additional funding for the U.S. Postal Service, some patients report delays in receiving their medications.

An Ipsos poll found one in five Americans got medication through the mail in the past week, and one in four of them – or 5% of all Americans – experienced a delay or non-delivery."

Read the full source news article:  Prescription deliveries: Health care providers urge patients to be proactive as COVID pandemic, USPS troubles cause delays - USA Today

Monday, August 24, 2020

SkillsPlus International Inc | Exemptee Training

California HMDR Exemptee Training | SkillsPlus Intl Inc.

FOR HOME MEDICAL DEVICE RETAILERS (HMDR)

SkillsPlus International Inc.'s Exemptee certification course is accepted by the California Department of Public Health - Food and Drug Branch. Successfully passing an HMDR Exemptee certification course is one of several requirements necessary for an individual to obtain an Exemptee license.

Take This Course If You Are Responsible For Oversight

If you are ultimately responsible for overseeing prescription devices (including business owners, chief executive officers, general managers and compliance officers), you'll want to be familiar with applicable laws, rules, and regulations.

Take This Course If You Are Applying For An Exemptee License

This online training course meets application requirements for anyone applying for an Exemptee License through the California Department of Public Health (CDPH).

Specifically, if you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application. The course completion certificate you earn is accepted by the licensing authority, the California Department of Public Health.

Learn More - Buy Now - California HMDR Exemptee Online Training Certification Course

  • $525 per student
  • Accepted by the California Department of Public Health (CDPH) - Food and Drug Branch
  • Earns a CDPH-recognized course completion certificate
  • Online training classroom available 24 x 7
  • More than 6,000 students have taken our state license-related courses
  • The longest continuously offered class for HMDR Exemptee license applicants
This training course meets application requirements for anyone applying for an Exemptee License through the California Department of Public Health.

FAQ - California HMDR Exemptee Training

Question: Who offers California HMDR Exemptee Training Certification?
Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).

Keywords and Phrases

#HMDR #HME #DME #HMEexemptee #Exemptee #approved #accepted #recognized #certified #training #eLearning #web #online #certificate #certification #course #class #program #event #webinar #seminar #workshop #provider #vendor #seller #registration #enroll #CDPH #”Food and Drug Branch”

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
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Who Offers Live Onsite GMP Training?
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The Designated Rep and Exemptee Professionals Blog
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, July 31, 2020

Exemptee Training - California Department of Public Health

Exemptee Training - California Department of Public Health (presented by SkillsPlus International Inc.)

  • If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.
  • Accepted by the California Department of Public Health (CDPH) - Food and Drug Branch
  • Earns a CDPH-recognized course completion certificate
  • Online training classroom available 24 x 7
  • More than 6,000 students have taken our state license-related courses
  • The longest continuously offered class for HMDR Exemptee license applicants. Go with our experience!

California HMDR Exemptee Online Training Certification Class

Questions?


FAQ - California HMDR Exemptee Training

Question: Who offers California HMDR Exemptee Training Certification?
Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).

Keywords & Phrases
#HMDR #HME #DME #HMEexemptee #Exemptee #approved #accepted #recognized #certified #training #eLearning #web #online #certificate #certification #course #class #program #event #webinar #seminar #workshop #provider #vendor #seller #registration #enroll #CDPH #”Food and Drug Branch”

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
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Who Offers Live Onsite GMP Training?
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The Designated Rep and Exemptee Professionals Blog
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, June 12, 2020

California Designated Representative Training Course ... and even more courses!

California Designated Representative 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 by taking any one of our California Designated Representative training courses.

Did you know that SkillsPlus International Inc. teaches three (3) distinct Board-approved California Designated Representative training courses for:

  1. drug/device wholesalers
  2. 3PL (third-party logistics providers)
  3. reverse distributors (BTW, we're the only Board-approved provider for this license type)

Learn more about our ...

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):
#CaliforniaDesRep
#CaliforniaDesignatedRepresentative

Friday, May 8, 2020

California Designated Representative Training Courses

All three (3) of the California Designated Representative training courses by SkillsPlus International Inc. are approved by the California State Board of Pharmacy. These courses cover the required topics specified in the respective California Designated Representative license application (for wholesalers, 3PL, reverse distributors).

Benefits & Features

  • Approved by the California State Board of Pharmacy
  • Earns a Board-recognized training affidavit
  • Online training classroom available 24 x 7
  • More than 6,000 students have taken our state license-related courses
  • Offered continuously since 2002
All three (3) of the California Designated Representative training courses by SkillsPlus International Inc. are approved by the California State Board of Pharmacy. These courses cover the required topics specified in the respective California Designated Representative license application (for wholesalers, 3PL, reverse distributors).
All three (3) of the California Designated Representative training courses by SkillsPlus International Inc. are approved by the California State Board of Pharmacy. These courses cover the required topics specified in the respective California Designated Representative license application (for wholesalers, 3PL, reverse distributors).

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, April 21, 2020

Florida Certified Designated Representative (CDR) Training And Wholesale Distribution Compliance

Over the years, we've fielded many questions revolving around the Florida Certified Designated Representative license.  Of chief interest, is how to go about preparing for the State of Florida Certified Designated Representative Laws & Rules Examination.

I've invited Dr. Sharon B. Roberts* (an expert in the regulatory realm of pharmaceuticals and wholesale drug distribution, and founder of CDR Resource Center) to share some thoughts and introduce the services that CDR Resource Center can provide:
  • Florida Certified Designated Representative (CDR) laws and rules examination preparation
  • Consulting expertise in prescription drug regulations and wholesale distribution compliance

Online Florida CDR Training By CDR Resource Center - Automated Online Training & Testing


All Prescription Drug Wholesale Distributors (including virtual BROKER -ONLY), companies that are seeking to do business in or with the State of Florida, are required to have a full-time Florida licensed Certified Designated Representative, (CDR). To become a FL licensed CDR a candidate must pass a laws and rules exam administered by the State of Florida.  CDR Resource Center has been training FL CDR candidates for over 12 years for the very difficult State exam.

Training for the State exam is offered in three ways:
  1. CDR Resource Center offers online virtual training allowing the candidate to study at their own pace from any computer.  The virtual training consists of 15 modules of educational and study materials, 100s of sample test questions and timed mock 40 question final exam. Register for FREE on our website - Try a quick FREE sample of the module style online training
  2. For the student who would prefer a live instructor, CDR Resource Center offers an 8 hour Webex with a live trainer.  The live training includes a bound law and rules manual, a pre-test, 7 hours of lecture and a post-test.   The live training can be purchased online in the Compliance Consulting section of the cdrresourcecenter.com
  3. For the candidate who has taken the State exam already and does not want to take a full course, we offer hourly consulting.  Bring us all your questions and purchase as much time as you’d like.  We can discuss your questions and point you to the correct answers. 

Additional CDR Resource Center Services


CDR Resource Center also provides state licensing support for the drug industry. Our company's licensing support services is unique to the industry allowing companies to pay as they go with no upfront onboarding fees or contracts.


*About Our Guest Blogger - Sharon B. Roberts

Sharon Roberts, PharmD, JD, CDR
Sharon Roberts, PharmD, JD, CDR

Sharon Roberts, PharmD, JD, CDR has over 25 years in the Pharmaceutical industry as a Registered Pharmacist and practicing Florida lawyer. She then became licensed as a Certified Designated Representative (CDR) and worked for the Department of Business and Professional Regulation Drug, Device and Cosmetics Program of the State of Florida where she was a State Inspector/Drug Agent inspecting businesses involved in the manufacture, purchase, storage and sale of prescription and over-the-counter drugs, devices and cosmetics. As part of this experience she became intimately familiar with the Florida Drug, Device and Cosmetic Act. The contents of this Act are the basis of the studies required to become a State Certified Designated Representative (CDR). Combining all her experience, she founded CDR Resource Center which offers over 25+ years of experience in the regulatory realm of pharmaceuticals and wholesale drug distribution.

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Saturday, March 7, 2020

California Exemptee Certification - training for home medical device retailers (HMDR)

California Exemptee Certification - training for home medical device retailers (HMDR)

  • $525 per student. 
  • Earns a course completion certificate accepted by the California Department of Public Health.
  • Covers required topics specified in the Exemptee license application form

Learn more!
Buy now!

More than 6,000 students have taken our state license-related training programs.

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California Exemptee Certification - training for home medical device retailers (HMDR). $525 per student. State approved by the CDPH. Earns a course completion certificate suitable for your Exemptee license application.
California Exemptee Certification - training for home medical device retailers (HMDR). $525 per student. State approved by the CDPH. Earns a course completion certificate suitable for your Exemptee license application.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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."
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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Who Offers Live Onsite GMP Training?
Free GMP Training Tips

The Designated Rep and Exemptee Professionals Blog
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 

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