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

• FDA cGMP QSR GMP Online Training - popular cGMP online training courses offered by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training

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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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
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SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

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

• FDA GMP QSR cGMP Online Training. Respected GMP online training courses - provided by SkillsPlus International Inc.

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

• GMP Online Training Courses.  FDA GMP QSR cGMP Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training

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

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

• FDA cGMP QSR GMP Training. Highly regarded online training classes taught by SkillsPlus International Inc. 

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 FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

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

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Millions of Americans receive drugs by mail. But are they safe? - NBC News

 According to the article:

"Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs. 

An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather.  ...

Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold."

Read the full source article:  Millions of Americans receive drugs by mail. But are they safe? - NBC News

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

•  FDA GMP QSR cGMP Training - recommended online training courses

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."

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What to Know About At-Home Oxygen Therapy - FDA . gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
• California HMDR Exemptee Online Training Certification Course

Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy

Giving yourself too much or too little oxygen can be dangerous. Talk with your doctor & get a prescription before buying an oxygen concentrator for use at home.

Read the full source article:  Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy - FDA.gov

According to the article:

"One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.

You should not to use an oxygen concentrator at home unless it has been prescribed by a health care provider. Giving yourself oxygen without talking to a doctor first may do more harm than good. You may end up taking too much or too little oxygen. Deciding to use an oxygen concentrator without a prescription can lead to serious health problems such as oxygen toxicity caused by receiving too much oxygen. It can also lead to a delay in receiving treatment for serious conditions like COVID-19.

Even though oxygen makes up about 21 percent of the air around us, breathing high concentrations of oxygen may damage your lungs. On the other hand, not getting enough oxygen into the blood, a condition called hypoxia, could damage the heart, brain, and other organs.

Find out if you really need oxygen therapy by checking with your health care provider. If you do, your health care provider can determine how much oxygen you should take and for how long."

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

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

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.

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 

FAQ: What is a California Designated Representative training affidavit?

• 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.
  Buy now, courses for:  Wholesalers | 3PL | Reverse Distributors

Read the full source article:  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

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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

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

Updated April 11, 2024

The original link broke.

You might also be interested in:

Dental Amalgam Fillings - FDA.gov

---  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
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CA Designated Representative Training Program
California Designated Representative Training Program
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Exemptee Certification Class
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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?

• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

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California Board of Pharmacy Designated Representative 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 

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

SkillsPlus International Inc | Exemptee Training

California HMDR Exemptee Training | SkillsPlus Intl Inc.

FOR HOME MEDICAL DEVICE RETAILERS (HMDR)

Buy now! California HMDR Exemptee Training

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. No extra fees to retake quizzes. 
• 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
• Nearly 10,000 students have taken our state license-related courses
• The longest continuously offered class for HMDR Exemptee license applicants
• 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. 

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”

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

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

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 

Exemptee Training - California Department of Public Health

• SkillsPlus Intl Inc. Online Exemptee Training (accepted by the CDPH) - Buy now!

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
• 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. 
• Nearly 10,000 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

• learn more
• buy now ($525 per student). No extra fees to retake quizzes. 

Questions?

• Give us a call:  (415) 948-5220

SkillsPlus International Inc. Online Exemptee Training (accepted by the California Department of Public Health - Food and Drug Branch)

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

#2024 #2025 #2026

#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”

FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

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

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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FDA cGMP QSR GMP Training - 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
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California Designated Representative Training Course ... and even more courses!

• The largest assortment of California Designated Representative training. Board approved. Buy now for:  Wholesalers | 3PL | Reverse Distributors

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 ...

California Designated Representative Training Courses!

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

#CaliforniaDesRep
#CaliforniaDesignatedRepresentative

COVID-19 - How To Protect Yourself And Others - CDC.gov

The pandemic is not over yet!

The CDC tells us:

How to Protect Yourself & Others

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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 

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).

• The largest selection of Board-approved California Designated Representative online training programs for:  3PL | Wholesalers | 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
• nearly 10,000 students have taken our state license-related courses
• Offered continuously since 2002

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.

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):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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

• Online Florida CDR Training by CDR Resource Center
• People also search for California Designated Representative wholesaler training

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 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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You might also be interested in:  California Designated Representative training programs for wholesalers, 3PL, reverse distributors

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

• 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. No extra fees to retake quizzes. 
• 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!

Nearly 10,000 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.

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

• FDA GMP QSR cGMP online training courses taught by SkillsPlus International Inc.

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
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 

FDA cGMP Training - online training courses by SkillsPlus International 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.

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FDA calls states’ bluffs on drug importation - STAT News

• California Designated Representative Training - for wholesalers, 3PL. $525 per student. Board approved. Earns a training affidavit suitable for your license application.
• People also buy these California Des Rep training classes for:
       Wholesalers | 3PL | Reverse Distributors

According to the article:

"For decades, critics of the U.S. drug pricing system have advocated importing drugs from Canada as a convenient shortcut to lower prices. The Food and Drug Administration’s recent release of a proposed regulation to create a process for approving state-sponsored importation plans is one step closer to that goal. A closer look shows that it’s actually a false step."

Read the full source article:  FDA calls states’ bluffs on drug importation - STAT News

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California Designated Representative Training - for wholesalers, 3PL. $525 per student. Board approved. Earns a training affidavit suitable for your license application.

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 

California Designated Representative Training - SkillsPlus International Inc.

• California Designated Representative Online Training Programs. Board approved. Earns a training affidavit suitable for your license application. Buy now, courses for:
       Wholesalers | 3PL | Reverse Distributors

California Designated Representative Online Training Programs - for wholesalers, 3PL, reverse distributors. Board approved. Earns a training affidavit suitable for your license application.

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 

Parents, grandparents to blame for half of child poisonings, study says - CNN

Read the full article:  Parents, grandparents to blame for half of child poisonings, study says - CNN

Here's the scoop:

"The study found that as caregivers take their meds out of tough-to-open containers and put them in easy reach places for convenience, they are inadvertently contributing to some 50,000 emergency room visits by kids every year who swallow dangerous pills when adults aren't paying attention."

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