Free Tips – FL Certified Designated Representative Exam

It’s a high-stakes test. Follow these free tips to get ready for the Florida CDR laws & rules examination.

  • Find out everything about the exam – Read the official candidate information booklet from start to finish.
  • Decide the best way to personally learn the subject – If you prefer self-study, then consider this FL CDR Exam Prep Course.
  • Block out time to get ready – Studying & prepping take time. Make the commitment to identify and protect this time.
  • Study in spurts and take long breaks –  Let’s admit it. Getting ready for a test isn’t much fun. However, studying in small chunks, and getting needed breaks makes it more tolerable.
  • Use many resources in studying and preparing – for example, reference these collections of online laws & rules:  FL DBPR; DRE blog
  • Practice, practice, & practice – Drill sample questions to discover your weaknesses.
    • Simply reading or listening to the regulations won’t get you ready.  You’ll also want to constantly assess your mastery of the rules, correct your misunderstandings, and reinforce what you should know. The following class helps you study, and gives you the opportunity to take lots of practice exams:  FL CDR Exam Prep Course.
  • Think ahead – Your test preparation counts for a lot, and don’t forget to learn everything you can about what to expect before you arrive at the testing center.

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FL CDR exam prep course

Training for FL Certified Designated Representative (CDR) license applicants

7 eLearning Dos And Don’ts For Successful Online Learning – eLearning Industry

Here’s a teaser tidbit from a blog post that was really well written.  Seven free tips on how to approach your online learning experience.

“Being in control of your own motivation doesn’t mean that eLearning should be a grueling challenge in self-discipline, though. You simply might need to adjust your strategy a bit. For a successful eLearning journey, there are some basic eLearning dos and don’ts that will ensure you get the very best from your effort and motivation.”

Read all 7 free tips: Source: 7 eLearning Dos And Don’ts For Successful Online Learning – eLearning Industry


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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


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New Pharmacy Laws for 2015 – California Board of Pharmacy

A gavel sitting on top of two red law booksJust posted, the CA Board of Pharmacy – California Law Changes for 2015 (PDF).

It covers all code sections that were added or amended during the 2014 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2015.


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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)


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HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

President Obama signing new law“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S.

The law will transform how the domestic supply chain operates to the benefit of healthcare providers and pharmacists — and their patients. HDMA and the nation’s primary pharmaceutical distributors have long advocated for this national solution.

With enactment of the law:

All existing state pedigree requirements that went above and beyond the Prescription Drug Marketing Act (PDMA) of 1987 are immediately preempted. The baseline requirements of the original law will remain in place until January 1, 2015, when statutory requirements, assisted by guidances currently being developed by FDA, will go into effect.

In 2015, enhanced product tracing requirements begin, which over 10 years, will lead to the establishment of a single system of federal electronic, unit-level traceability requirements across the entire supply chain.

National distributor licensure standards also have been strengthened. Instituting strong, consistent distributor licensing standards is a critical component in ensuring that the supply chain remains safe and secure.”

Read the full article, and reference a great collection of fact sheets and educational material about this subject: via HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act.


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Design Considerations for Devices Intended for Home Use – FDA Guidance

Medical Device Development Pathway

Read the full guidance:  Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB)

As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.”


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FDA DSCSA Workshop – Meeting Materials

Follow the link below to the FDA webpage of all related meeting materials and notices:

“[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs, in addition to the feasibility of establishing standardized documentation to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.” – – – via News & Events > Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.

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Apply for a Designated Representative License – CA Board of Pharmacy

Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications:

“Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License.


 

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About The HMDR Licensing Program

Follow the link below to learn more about the California HMDR Licensing Program:

“Welcome to the home page for the Home Medical Device Retailer (HMDR) licensing program. The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.” . . .

via HMDR Licensing Program Home Page.

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