Showing posts with label prep. Show all posts
Showing posts with label prep. Show all posts

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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Friday, November 14, 2014

Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

Updated July 30, 2021

Sadly, the original link broke.

---  the original post follows below  ---

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

'via Blog this'

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Thursday, January 24, 2013

FDA Inspection - Tips by the FDAzilla Blog

English: FDA Inspector LCDR Teresa Fox (USPHS)...
A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

'via Blog this'


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The Exemptee Institute
The Designated Representative Institute

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Wednesday, January 18, 2012

FDA Inspection Preparation

Don't get surprised!  Prepare yourself well in advance of an FDA inspection.

But if you should find yourself on the brink of one in a week or so, here's something helpful:
Rapid Deployment Tips to Prepare for an Inspection Quickly by John Avellanet (PDF)

If you're not so much in a rush, then invest some time in getting prepared.

You might be interested in:
Surviving an FDA Inspection - a live onsite training class

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Wednesday, February 9, 2011

Preventive Anti-HIV Drug Use - Cautious Prescribing


In a nutshell:
The report provides interim guidance to health-care providers based on the reported results of the trial, which indicated that tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) taken orally once a day as preexposure prophylaxis (PrEP) is safe and partially effective in reducing HIV acquisition among MSM when provided with regular monitoring of HIV status and ongoing risk-reduction and PrEP medication adherence counseling.
You might also be interested in:
The CDC on Pre-Exposure Prophylaxis (PrEP)

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Wednesday, June 3, 2009

FDA Audit Preparation - Audit Theory - Be Ready

This Pharma Compliance Blog post, The Role of Affect in your Culture of Compliance, resonates with me. I think in principle, the core idea about being prepared for audits, extends well beyond GMP regulated industries. The takeaway for me is, of course your paperwork needs to be in order, AND your people have to prepped from an emotional and behavioral standpoint.

Related Posts:
21 CFR Part 820 QSR Audit Checklist - Are you ready?
Free 21 CFR Part 820 QSR Audit Checklist

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - GMP Compliance Training Experts
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The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, January 23, 2009

HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword

Pre-exposure prophylaxis (PrEP) against HIV infection just got a huge spotlight, in this ABC News article, ABC News Examines Pre-Exposure Prophylaxis For HIV Prevention. It seems that HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection. Part of the debate is whether approval of such pills could lead some high-risk groups to forgo safe sex practices such as condom use.

After reading this, I'm wondering if we should all be worried about prEP usage without safe sex practices. Are you worried?

Related Posts:
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
HHS Updates HIV Treatment Guidelines (free pdf)
HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

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