Showing posts with label designated. Show all posts
Showing posts with label designated. Show all posts

Wednesday, October 17, 2012

What Is A Pharmacy Designated Representative?


Updated June 27, 2018

California Designated Representative Licenses


Now there are more California Designated Representative license types (including, but not limited to):
  • California Designated Representative - Wholesaler
  • California Designated Representative - 3PL (third-party logistics provider)
  • California Designated Representative - Reverse Distributor
If you're applying for any one of these licenses, you might be interested in the following training courses. Successful completion earns a training affidavit (accepted by the California Board of Pharmacy):

Training programs for California Designated Representative license applicants  -  Earn a training affidavit

- -  the original post follows below  - -

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.
The trick then becomes finding a way to fulfill the training program requirement.

SkillsPlus International Inc. offers designated representative training for California and Florida, so you might be interested in:


The Designated Representative and Exemptee Blog

CA Home Medical Device Retailer (HMDR) Exemptee online CBT training certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog

Tuesday, January 3, 2012

About Florida Certified Designated Representative (CDR)

Florida Department of Business and Professional Regulation - Certified Designated Representative:
"Drugs, Devices, and Cosmetics Program - Certified Designated Representative: All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."
'via Blog this'

Learn about the FL CDR program at the webpage above. It covers:
  • requirements
  • application
  • certification criteria
  • operational requirements
  • fees
You might also be interested in:

Florida Designated Representative Study Course: online web training by CDR Resource Center

California Designated Representative Training - for wholesalers, 3PL, reverse distributors

Return to SkillsPlus International Info Blog - Home

Wednesday, December 14, 2011

Florida Designated Representative - Online Exam Preparation Course


For Designated Representative license applicants:


     Florida:

     California (earn a training affidavit):

----------------  original post follows below  --------------------


Florida Designated Representative Exam Preparation Course: SkillsPlus International Inc.:
"Florida requires Designated Representatives working at drug and device wholesalers to be trained in specific Florida Pharmacy Laws. SkillsPlus offers an on line self study course that helps prospective Designated Representatives to prepare for the examination. Simply enroll and follow the links in a confirmation email and you are on your way."
'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 


Monday, November 14, 2011

Pearson VUE: Florida Certified Designated Representative

Pearson VUE: Florida Certified Designated Representative - Drugs, Devices and Cosmetics:  

The Pearson VUE website contains specific information about Florida Certified Designated Representative - Drugs, Devices and Cosmetics testing. Register for your next exam, find test information, or download handbooks/applications/forms from this page.

You might be interested in:
Florida Certified Designated Representative Study Course - an online training

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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Related articles

Tuesday, November 8, 2011

Find Nearest Test Center for FL Certified Designated Representative Exam

Find The Nearest Test Center for The FL Certified Designated Representative Exam - Pearson VUE:    'via Blog this'
A link to help you locate a test center near you for the Florida CDR (Certified Designated Representative) Exam. (Tip:  the link is on the right hand side of the page)
You might also be interested in:
Florida Certified Designated Representative Exam Study Course by CDR Resource Center

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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Related articles

Thursday, September 22, 2011

Ready For Drug Pedigree Rules?

Updated November 10, 2022

The original post didn't age well.

You might also be interested in:
  • Board-approved California Designated Representative courses: 

---  the original post follows below  ---

I recently attended a conference that included representatives from the European, Asian, and U.S. regulatory agencies. At that meeting there was much discussion around pedigree rules. Some of the concerns expressed begin with importing drugs and bulk actives (now called active pharmaceutical ingredients (APIs)). At this level, manufacturers are required to qualify supplies. This means that a manufacturer must actually visit the API manufacturing site to assure themselves, and the public, that the production facility shown to the auditor is the actual site of manufacture, and that there is no "shadow site" where the real work takes place. Internationally, there are different approaches to the pedigree. In Europe there is exploration with a "book ends" approach. This approach requires the manufacturer to issue the initial pedigree. The next pedigree touchpoint is at the pharmacy when the product is dispensed to the patient. The thinking is that if the product is moving between known distribution channels, then the product is protected. The U.S. requirement is to document every change in ownership. This means that every touchpoint is documented. Yes, regulators in Europe realize that this approach probably provides better assurance of the supply chain. However, they are also concerned about how much work to pass on to the smaller distributors who may not be staffed for this level of documentation. Learn more about e-Pedigree in our online computer-based training (CBT) courses:
  • CA Designated Representative Certification Course by SkillsPlus International Inc.
  • FL Designated Representative Training Course by SkillsPlus International Inc.
Return to SkillsPlus International Info Blog - Home 
SkillsPlus Intl Inc. - GMP Compliance Training Experts

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Monday, September 5, 2011

e-Pedigree - CA Board of Pharmacy


Updated August 30, 2020

You might also be interested in:  Epedigree - Wikipedia


- - -  the original post follows below  - - -

We'll be attending the Sept 7th CA Board of Pharmacy meeting, where one of the agenda items is e-Pedigree ...




Updated 12/6/2011:
The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - GMP Compliance Training Experts
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Tuesday, August 2, 2011

Florida Certified Designated Representative (FL CDR) Exam Prep


Updated September 7, 2021

Unfortunately the glossary widget is no longer available.

---  the original post follows below  ---

Florida Certified Designated Representative (CDR) Examination Preparation


Preparing to take the Florida Certified Designated Representative (FL CDR) Exam is challenging.

So what you need are some solid exam preparation tools, including this Florida Certified Designated Representative (FL CDR) glossary widget by SkillsPlus International Inc.

If you have any questions about what a term means, chances are you'll find the definitions here!

Tuesday, July 26, 2011

California Designated Representative Training Course for Wholesalers - Very Popular

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

People also search for our:  3PL Course | Reverse Distributor Course

Learn more about our very popular online training course:
California Designated Representative Wholesaler Training by SkillsPlus International Inc.


You need to take this online training course, because it's so convenient!
  1. It's available to you 24/7, anytime you want.
  2. It's online computer-based training that you can take in the comfort of your home or office
  3. There's no need for you to travel!
Learn the requirements of a Designated Representative for the State of California. This class meets the requirements for the State of California Designated Representative. This is an on-line self-study pre-recorded presentation with animation and text. Each presentation is followed by the final exam for that section of the class. This class allows you to study from the convenience of your home or office.

Simple FAQs about this training course