Friday, June 12, 2020

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

California Designated Representative Training Course ...  


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).

---------------

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.

----------------

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

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 

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

FDA calls states’ bluffs on drug importation - STAT News

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

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

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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.
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
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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 

Thursday, February 13, 2020

California Designated Representative Training - SkillsPlus International Inc.


California Designated Representative Online Training Programs - for wholesalers, 3PL, reverse distributors. Board approved. Earns a training affidavit suitable for your license application.
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
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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 

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
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 

Saturday, February 1, 2020

California Exemptee Training - for HMDR home medical device retailers

  • $525 per student
  • Accepted by the California Department of Public Health (Food and Drug Branch)
  • Earns a course completion certificate

California HMDR Exemptee online training certification program
California HMDR Exemptee online training certification program












































































































#HMDR #HME #DME #HMDRexemptee

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

---------------------

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
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 

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  - 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.

Courses Coming Soon!

  • Buildings and Facilities (Coming 2019) - This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Surviving an FDA Inspection  (Coming 2019) - Learn what to expect, how to plan for an inspection, and how to behave. This program has demonstrations of interviews and different response strategies. Some are intended to be humorous, while some are common mistakes made when interacting with the FDA. Use this program to plan for your next inspection.
  • Understanding Validation  (Coming 2019) - Delve into the intricate rules and practices of validation. This course is based on guidance documents on validation. The concepts of validation are explained in simple language. This is a great introduction to validation as well as preparation for the plant's next major validation initiative.
  • Contamination Control  (Coming 2019) - This topic discusses the sources of contamination and methods to prevent contaminating products. This is a great session for new employees needing to learn about the risks and proper behaviors to controlling contamination. Use this program as part of a corrective or preventive action as a result of contamination control breaches.
  • Materials and CGMP  (Coming 2019) -  This topic traces the CGMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.
  • Organization and Personnel  (Coming 2019) -  This topic summarizes the essential elements of 21CFR211 Subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.
  • Production and Process Control  (Coming 2019) -  This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Implementing A Successful Change Control Program (Coming 2019) - This program reviews the requirements of change control and components of a successful change control program.

Friday, December 13, 2019

Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

Read the full article:  Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

Texas doctor faces contentious issues as he assumes helm of sprawling agency

"Stephen Hahn, an oncologist and top official at MD Anderson Cancer Center, was confirmed Thursday as commissioner of the Food and Drug Administration. The Senate vote was 72 to 18.

Hahn, 59, takes over as the FDA juggles vexing political and health issues, including the Trump administration’s still-unresolved response to a surge in underage vaping over the past two years."

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

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 

Thursday, December 12, 2019

‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT



Read the full article:  ‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

According to the article:

"Over the past decade, cocktails of drugs from opioids to antidepressants have been showing up in rivers all over the U.S. Studies have detected these chemicals in the bodies of fish and aquatic insects, altering behaviors that are key to survival. Now, an investigation by STAT and Type Investigations identifies for the first time major drug companies that are likely dumping substantial quantities of drugs from their manufacturing facilities into rivers and streams."

From SkillsPlus International Inc.

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