Showing posts with label workshop. Show all posts
Showing posts with label workshop. Show all posts

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
  • 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).
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):

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. 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.
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.


Saturday, November 30, 2019

The only Board-approved California Designated Representative training program for reverse distributors

The only Board-approved California Designated Representative training program for reverse distributors

According to the California State Board of Pharmacy - Designated Representative-Reverse Distributor License webpage, there is only one Board-approved California Designated Representative training program for reverse distributors (offered by SkillsPlus International Inc.).

About This Course
  • an online training class, available 24 x 7
  • designed specifically for reverse distributors, and covers all topics specified in the Board's license application
  • costs $625 per student
  • earns a Board recognized training affidavit
  • Learn more
  • Buy now!

California Designated Representative online training programs for wholesalers, 3PL, reverse distributors. Board-approved. Earns a training affidavit.
California Designated Representative online training programs for wholesalers, 3PL, reverse distributors. Board-approved. Earns a training affidavit.

#CaliforniaDesRep
#CaliforniaDesignatedRepresentative


Saturday, August 10, 2019

What is a California Designated Representative training course? - Yahoo Answers

View the full text Q&A:  What is a California Designated Representative training course? - Yahoo Answers (sorry, this link is no longer available 6/1/2021)

"First, some background. The California State Board of Pharmacy (the "Board") is in charge of licensing companies that are drug-device wholesalers, third-party logistics providers (3PL), and reverse distributors, and more. This means these companies need to get a facility license from the Board to run their businesses."

Continue reading >>

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Largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.
Largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.


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, August 3, 2019

California Designated Representative Online Training Programs - 6,000 students trained!

Introductory video about California Designated Representative training:




Go to:  The Designated Representative and Exemptee Blog

#CaliforniaDesignatedRepresentative
#CaliforniaDesRep
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California Designated Representative Online Training Courses. Board-approved. Earns a training affidavit accepted by the Board. 3 distinct classes for: wholesalers, 3PL, reverse distributors. 6,000 students trained.
California Designated Representative Online Training Courses. Board-approved. Earns a training affidavit accepted by the Board. 3 distinct classes for: wholesalers, 3PL, reverse distributors. 6,000 students trained.

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, July 23, 2019

FDA warns company marketing unapproved cannabidiol products - FDA.gov

Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety  -  Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD - FDA.gov


According to the news release:
"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.  ... 
The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."
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Online FDA cGMP QSR GMP Training Courses

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, June 12, 2019

F.D.A. tackling C.B.D. in food - Food Business News

Read the full article:   F.D.A. tackling C.B.D. in food - Food Business News


"Stakeholders in the manufacture, distribution, use and regulation of products containing cannabis or cannabis-derived compounds, such as cannabidiol (C.B.D.), had their say before a panel of Food and Drug Administration officials during a daylong public hearing held May 31 at the agency’s White Oak Campus in Silver Spring, Md. More than 400 individuals and associations applied to address the panel; more than 100 were able to do so."

According to "Amy Abernethy, Ph.D., the F.D.A.’s deputy commissioner ... “Key questions about product safety need to be addressed. Data are needed to determine the safety thresholds for C.B.D … There are both positive supporters of cannabis and cannabis-derived products including C.B.D. and also concerned citizens worried that widely available products can be harmful.”"

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FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP 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 17, 2018

CGMP and QSR Trainer Certification Program

GMP Trainer Courses

GMP Trainer Awareness, Certification, and Master Trainer Course

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
  • This class is implemented in three phases: Awareness, Certification and Master Trainer.
  • This is NOT a public seminar workshop. Our public seminar was so popular, we turned it into an online self-study course that fits into your busy schedule.

Keywords:   FDA cGMP GMP QSR, Train the Trainer, Train-the-Trainer, Train-The-Trainer, GMP Trainer Certification, cGMP Trainer Certification, QSR Trainer Certification, FDA Trainer Certification, GMP Trainer Awareness Course, GMP Master Trainer Course, Training For Trainers, Trainer Education

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

Monday, October 3, 2016

FDA Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products


Read the full article: Guidance Documents & Regulatory Information by Topic > Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products - FDA.gov:

"The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations."

'via Blog this'

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cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, August 15, 2016

FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance: FDA Law Blog

FDA Law Blog: FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft Guidance:

"Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft of the same name that was issued in July 2011."

'via Blog this'

Read the FDA guidance:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)


cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

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Friday, July 22, 2016

Basic GMP Training - A course focusing on cGMP basics

Updated May 13, 2025:

Clients are now requesting online training courses:


---  the original post follows below  ---

This live onsite course teaches the FDA cGMP basics, "Essentials for Pharmaceutical Manufacturers."

Designed for new employees and refresher GMP training for your seasoned staff.

#FDA #GMP #cGMP #training #course #class

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thursday, December 17, 2015

America's 'Third Wave' Of Asbestos Disease Upends Lives : Shots - Health News : NPR


Read the full article: America's 'Third Wave' Of Asbestos Disease Upends Lives : Shots - Health News : NPR:

"The fire-resistant mineral first had killed asbestos miners, millers and manufacturing workers. Then it had taken out insulators, shipbuilders and others who worked with asbestos products. Eventually, conference attendees agreed, it would be roused from its dormant state in pipes, ceiling tiles and automobile brakes and kill again."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
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Friday, June 12, 2015

Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News


Read the full article: Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News:

"Sleeping pills such as Ambien and Restoril may double someone's risk of a car crash — even after their effects should have worn off — and may raise the risk as much as having too much to drink, researchers reported Thursday.

A close look at medical and driving records showed that people who took any one of the three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Wednesday, May 27, 2015

Hurricane Safety Checklist - FDA Public Health Focus

Updated September 4, 2024:

The original link broke.

You can still read about the same topic here, on FDA.org:
https://www.fda.gov/consumers/consumer-updates/hurricane-season-be-prepared

---  the original post follows below  ---

View the entire checklist: Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to:" . . .

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Friday, May 8, 2015

Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business


Read the full article: Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business:

"Criminal attacks against health-care providers have more than doubled in the past five years, with the average data breach costing a hospital $2.1 million, according to a study today from the Ponemon Institute, a security research and consulting firm. Nearly 90 percent of health-care providers were hit by breaches in the past two years, half of them criminal in nature, the report found."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, May 6, 2015

Root Cause Analysis for Better Deviation Investigations - GMP Training

Root Cause Analysis for Better Deviation Investigations - A cGMP Training Course

A top reason why companies receive a 483 is a deficiency in the deviation investigation process. In our experience, most employees need deviation investigation training, and here's why:
  • Staff struggle to solve problems
  • Teams often fail to get results
  • The pharma and biotech sector repeatedly demonstrate difficulty in complying with FDA expectations for thorough deviation investigations.
In this SkillsPlus International Inc. hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools. Allan Dewes, the lead instructor, has taught this course all over the world with exceptional results.

Call (415) 948-5220, or learn more: http://www.skillsplusinc.com/root_cause.htm

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Monday, May 4, 2015

Why Your Future Vaccination Might Not Be A Shot : NPR


Read the full article: Why Your Future Vaccination Might Not Be A Shot : Goats and Soda : NPR:

"Vaccines don't always make it into the people who need them the most. Many require a syringe and a needle to enter the bloodstream and create immunity. And that means a doctor or nurse has to do the job.

But with if a vaccine could be delivered by simply applying a patch? That's Mark Prausnitz's goal: creating a nickel-sized bandage-like device covered with 100 microscopic needles that would puncture the skin, then dissolve to get the vaccine into the body."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thursday, April 30, 2015

FDA seeks more data on safety of hospital hand cleaners - Yahoo News

Updated October 6, 2021

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Read the full article: FDA seeks more data on safety of hospital hand cleaners - Yahoo News:

"Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctors' offices and nursing homes to kill germs and prevent infections.

The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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From SkillsPlus International Inc.