FDA > DSCSA > Are you ready for the Drug Supply Chain Security Act?

Sign-up for a Board-approved California Designated Representative course now:
 - Wholesaler Training Course
 - 3PL Training Course
 - Reverse Distributor Training Course

Read the full article: Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act? - FDA.gov:

"There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

2014 Fall Conference Season Preview - RxTrace

View Dirk Rodger's annotated list of upcoming supply chain conferences at: 2014 Fall Conference Season Preview - RxTrace:

"Here are the events that have caught my eye for one reason or another, in chronologic sequence:"

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Related articles

• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  Florida Certified Designated Representative (CDR) Exam Prep
• 
  About The HMDR Licensing Program
• 
  CA Designated Representative & Exemptee Training Course - Enhanced for iPad

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

• California Designated Representative Training Courses for:
       Wholesalers | 3PL | Reverse Distributors
• FDA GMP Training Courses - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

More great stuff that's clear and easy to understand from Dirk Rodgers. Follow the link below to read his full post.

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace:

"From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  FDA DSCSA Workshop - Meeting Materials
• 
  FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
• 
  About The HMDR Licensing Program
• 
  Drug Supply Chain Security Act - Drug Supply Chain Security Act (DSCSA) Implementation Plan

FDA - Hurricane Checklist - Medical Devices

• Buy now! California HMDR Exemptee License Training Certification
• California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.

Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "  (follow the link above to the FDA's checklist)

More specifically for medical devices:

Medical Devices

• If you have a "life-supporting" or "life-sustaining" device that depends on electricity, you should contact your healthcare provider for information on how to maintain function in the event of a loss of power.
• Keep your device and supplies clean and dry. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
• For more information, see FDA Offers Tips about Medical Devices and Hurricane Disasters¹⁵ (en Español¹⁶).

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California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.

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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

No Significant Difference - Compares distance education to face-to-face

• People also look for Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  

Updated August 26, 2021

The original link broke.

You can still explore the exact same topic at this website:

No Significant Difference - DETA

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This body of research supports distance education as neither better or worse than face-to-face education.  Once you factor in cost and convenience, it would seem that online training is the big winner.

No Significant Difference - Presented by WCET:

"Does taking a course via distance education lower a student's chances for success as compared to the same student taking the same course in a face-to-face format?

Mr. Russell collected research studies addressing this question from as far back as 1928. The studies included in his collection involve a wide array of distance delivery modes including correspondence (printed materials sent out to students), radio, television, video, and online. Mr. Russell found that an overwhelming number of studies showed that when the course materials and teaching methodology were held constant, there were no significant differences (NSD) between student outcomes in a distance delivery course as compared to a face to face course. In other words, student outcomes in distance delivery courses were neither worse nor better than those in face to face courses. Mr. Russell referred to this collection of results as the "No Significant Difference Phenomenon", thus coining the now-common identifier phrase for this body of literature."

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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Reinforce Key Regulatory Messages - Use Posters

Updated 12/6/2022

The original links broke, as the posters are no longer available.

---  the original post follows below  ---

Drug wholesaler designated representatives and medical device exemptees often need to recruit the help of staff around them to ensure the company complies with regulatory requirements.

If you're looking to make your company's training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

By the way, if you think these posters don't apply to your work situation, I encourage you to think twice. Many of them apply to many diverse work settings. Folks have been clamoring for more work-related posters, so it's great to see these new additions to poster offerings. Check it out!

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