Showing posts with label quality. Show all posts
Showing posts with label quality. Show all posts

Monday, June 19, 2023

Caregivers, Patients Trade Blame for Equipment Delays, Study Finds - HomeCareMag

  • If you need a California HMDR Exemptee, they'll need CDPH-approved training to apply for their Home Medical Device Retail Exemptee license application.  Learn more & buy: California Exemptee Certification: California Exemptee Certification

According to the article: 

"The survey, which queried 500 home-based adult patients and 500 paid and unpaid caregivers, showed that both patients and caregivers are overwhelmed and stressed. Both groups equally (31%) blame each other when there is a delay in receiving life-saving medical equipment. Findings further exhibit that many patients are left in the dark, unaware of any coordinated assistance services made available by their health insurers. An overwhelming majority (77%) of the patients also reported that they are the primary contact for their medical suppliers. The survey also disclosed that 59% of patients received unreliable or poor-quality medical supplies and equipment."

Read the full source article:  Caregivers, Patients Trade Blame for Equipment Delays, Study Finds - Home Care Mag

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- - -

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
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Friday, August 23, 2013

FDA - Pharmacy Alert - Front Range Laboratories - Testing Concerns

Updated November 18, 2025

The original post didn't age well.

You might also be interested in:
Compounding: Inspections, Recalls, and other Actions - FDA.gov
https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions

---  the original post follows below  ---

Drug Safety and Availability > CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories:

"In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, July 9, 2009

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

Tuesday, June 16, 2009

Pharmacy Designated Representative Training Requirements

Pharmacy Designated Representative Training Requirements

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The trick then becomes finding a way to fulfill the training program requirement. I've posted links to training and certification service providers below.

Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative license applicants - Earn a training affidavit

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

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