Training Affidavit For California Designated Representatives

Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Looking for a California Designated Representative training program?

YOU NEED A TRAINING AFFIDAVIT – If you need a training affidavit as proof of completing a training program, as part of your California Designated Representative or  CA Designated Representative-3PL license application, then keep reading.

WE CAN HELP YOU
Buy one of our courses:  Designated Representative Training Programs by SkillsPlus Intl Inc.  –  These online self-study courses are $525 per student, and they are approved by the California Board of Pharmacy. Learn more about our CA Designated Representative training programs. When you’ve successfully completed a program, simply request your copies of completed training affidavits.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Home Medical Device Retail Exemptee Online Training Certificate – HMDR

The Home Medical Device Retailer Exemptee License Application requires proof of HMDR Exemptee training program completion.

SkillsPlus International Inc. offers an Exemptee training program (that covers topics specified by the California Dept of Public Health – Food and Drug Branch). Upon successful completion of this training course, the student will receive a certificate of completion, that is acceptable to the CDPH FDB.

Learn more about Exemptee training by SkillsPlus Intl Inc.
Buy and register now! – SkillsPlus Intl Inc. Exemptee Training Course

HMDR Exemptee Training

 


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“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”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation

Buy Now!
FL Certified Designated Representative (CDR) online exam prep course by SkillsPlus Intl Inc. – Lots of practice exams – Practice makes perfect! – Available around-the-clock 24 x 7


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

FDA letters on building blocks

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””

Read the full article: Source: FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FAQ: Who needs an HMDR License?

High tech graphic of medical devicesQUESTION: Who needs an HMDR license from the California Department of Public Health, Food and Drug Branch (CDPH/FDB)?

ANSWER: Any person conducting an HMDR business (retail facility or warehouse) in the State of California must first obtain a license from CDPH/FDB. A separate license is required for each location. The license must be renewed each year, and the license cannot be transferred to another location, business, or business owner. {FYI: Wholesalers of medical devices are not required to obtain an HMDR license, but may be required to obtain a permit with the Board of Pharmacy if they distribute prescription (Rx) devices for wholesale purposes} http://www.pharmacy.ca.gov

Sources:


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

FDA Recommends New Testing Standards for Home Use Devices | RAPS

FDA Logo for the CDRH“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.

Background

In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.

The latter category, often referred to as “home use devices,” is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.”

Read the full article: via FDA Recommends New Testing Standards for Home Use Devices | RAPS.

Read the final FDA guidance:
Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF)


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com

FDA Logo in blue“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines.

The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment until December 8.”

Read the full article: via SecuringIndustry.com – FDA publishes Q&A on DSCSA provisions.

View the FDA’s draft guidance: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers – FDA Draft Guidance For Industry (PDF)


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

Wishful Thinking?! Both Work Experience AND Training Are Required

eLearning - Online TrainingThis topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa.

In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing a training program that addresses key subjects/topics).

Work experience does not substitute for the training program, and the training program does not substitute for work experience.

References:

  1. Application For Home Medical Device Retailer Exemptee License – New And Renewal (CDPH Food & Drug Branch) – PDF  
  2. Designated Representative Requirements And Application (CA State Board of Pharmacy) – PDF

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Free Tips – FL Designated Representative (CDR) Exam Prep

Typing on a laptop during an online courseSimply studying for the Florida Certified Designated Representative (CDR) examination isn’t enough!

  1. Many candidates only study the exam subjects and content, then take what’s considered a difficult exam. Some of these same candidates don’t pass the exam.
  2. As you prepare for the examination, you have to recognize that the official exam of 40 multiple choice questions (in 1.5 hours) is the critical step toward moving forward in the licensing application process. That’s roughly 2.5 minutes per question, hardly enough time to rethink or rehash the answer choices.
  3. The keys to exam preparation include: reinforcing complete mastery of the exam content, reducing your anxiety, gaining confidence, and developing test taking familiarity, rhythm, and pace.

In the past, I’ve taken many high pressured timed exams, including healthcare clinical and web technology certification exams. In my experience, I learned that scouring the universe for any and all available practice exams helped me tremendously to prepare for the official examinations. I strongly recommend practice exams.

The Key Learning. Only by preparing for the most important part of the examination process, that is, actually taking the test, can you increase the odds of successfully passing the exam. As Vince Lombardi (football coaching legend) says, “Practice does not make perfect. Only perfect practice makes perfect.” So we recommend candidates take as many of our practice exams (in our SkillsPlus FL CDR Exam Prep Course), as frequently, successfully, and confidently, as possible, before sitting for the official state exam. We’re thrilled to receive continued feedback that our exam prep course has helped many students pass the official examination.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Florida Certified Designated Representative (CDR) Exam Prep

It’s always a pleasure to make people happy, and make their work lives easier, better, and more successful.

We recently got this feedback from a happy customer:

“Some of our staff have attempted the Florida CDR exam several times, and failed. More recently, in order to improve their chances of passing, those same staff have taken the FL CDR Exam Preparation Course offered by SkillsPlus International Inc. and have passed! As a result, our corporate office is recommending that our prospective designated representatives take the SkillsPlus exam preparation course,” a Director of Compliance Training said.

Learn more about: The Florida Certified Designated Representative (CDR) Exam Prep Course – by SkillsPlus Intl Inc.

View the FL CDR Candidate Information Booklet (CIB) – PDF


Go to DREprof.com: The Designated Representative and Exemptee Training Website