SkillsPlus International Inc. - The leader in compliance training

Updated July 2, 2026

SkillsPlus International Inc.

SkillsPlus International Inc.

The leader in compliance training

Specializing in:

• California Designated Representative training courses for license applicants
• California HMDR Exemptee training certification for license applicants
• FDA cGMP online training programs and courses

Learn more >>

Mailing Address

SkillsPlus International Inc.

1183 University Drive Ste 105-251
Burlington, NC
27215
USA

Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

• California Designated Representative Training Course for Wholesalers (approved by the California State Board of Pharmacy)

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Read the full editorial by Robert J. Kerwin:  Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

"In California, the Board of Pharmacy, which regulates matters pertaining to wholesaling of medical devices, is requiring sellers of medical devices who do not reside in California (“nonresident wholesalers”) to have a wholesalers’ license from their home state or else be subjected to a fine for conducting business in California without an appropriate license. This, despite the fact that many states do not issue medical device wholesalers’ licenses." 

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Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)

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

Most Medicare Claims for Replacement PAP Device Supplies Didn't Comply With Medicare Requirements - OIG

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California HMDR Exemptee Training Certification:

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

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Read the full June 2018 report:

Most Medicare Claims for Replacement Positive Airway Pressure Device Supplies Did Not Comply With Medicare Requirements - DHS OIG (PDF - click this link)

"Most Medicare claims that DME suppliers submitted for replacement PAP device supplies did not comply with Medicare requirements. Of the 110 claims in our sample, 24 complied with Medicare requirements; however, 86 claims with payments totaling $13,414 did not. On the basis of our sample results, we estimated that Medicare made overpayments of almost $631.3 million for replacement PAP device supply claims that did not meet Medicare requirements."

The CMS expressed interest in educating health care providers on avoiding Medicare billing errors.

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Training for HMDR Exemptee license applicants - Earn a course completion certificate - Accepted by the California Dept of Public Health (CDPH)

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 - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Exam 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

FDA To Dispensers - Guidance on DSCSA July & Nov Timelines

The FDA published a new guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry - FDA (PDF)

In a nutshell:

"The product tracing requirements in sections 582(d)(1) of the FD&C Act take effect for
dispensers on July 1, 2015. ... "

"FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act."

There's a whole lot more in the guidance, so you'll want to review it, in its entirety.

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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

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  Who Offers Designated Representative Training?

What is CMS going to cook up next for DME providers? - AAHomecare Blog

AAHomecare Blog: What is CMS going to cook up next for DME providers?:

"Speaking of requirements, did you know that 2010's Affordable Care Act will make having a compliance program mandatory for any provider who bills Medicare? That’s right: mandatory, as in the opposite of optional."

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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

SkillsPlus Intl Info Blog

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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SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog