California Designated Representative Training Course ... and even more courses!

• The largest assortment of California Designated Representative training. Board approved. Buy now for:  Wholesalers | 3PL | Reverse Distributors

California Designated Representative Training Course ...  

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any one of our California Designated Representative training courses.

Did you know that SkillsPlus International Inc. teaches three (3) distinct Board-approved California Designated Representative training courses for:

1. drug/device wholesalers
2. 3PL (third-party logistics providers)
3. reverse distributors (BTW, we're the only Board-approved provider for this license type)

Learn more about our ...

California Designated Representative Training Courses!

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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 - New!
• 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

#CaliforniaDesRep
#CaliforniaDesignatedRepresentative

FDA and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

Death By Dietary Supplement (Forbes) - Lamar Odom, etc.

USP launches new GMP audit certification program

By Stephen DANIELLS, 03-Nov-2015
There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement and dietary ingredient manufacturers.

= = = original post below = = =

This Slate article is an interesting read about the proliferation of dietary supplements, and the interest in tighter regulatory oversight.

Herbal supplement dangers: FDA does not regulate supplements and they can be deadly. - Slate Magazine:

"Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000."

'via Blog this'

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FDA Proposes Electronic Safety Reporting

The FDA states in their news release, FDA Proposes Mandatory Electronic Safety Reporting - New Rules will Help Strengthen Postmarket Safety Data Collection, that they've issued two proposed rules — one that applies to electronic medical device adverse event reporting, and one that applies to electronic drug and biologic product adverse experience reporting. The proposed rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review, and archive. Additional Information From the FDA:

• FDA’s Web site on Electronic Medical Device Reporting: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
• FDA’s Web site on the FDA eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
• Fact Sheet: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm179586.htm

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Fewer FDA Inspectors - More Device Complaints

Here's an excellent graphic crafted by Dan Nguyen and Christina Jewett, Graphic: At FDA, Fewer Inspectors Trace More Device Complaints. It's easy to understand that from 1997 through 2007, two major trends have emerged: 1) adverse event reports have risen dramatically over the years, and 2) the number of FDA FTEs in the medical device field division have steadily declined. What you have to do, to shock some reality into yourself, is to view their graphic. Go see it. 

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FDA - New CDRH Event Problem Codes

The FDA just published "CDRH Event Problem Codes. This CDRH website (with enhanced device and patient problem codes) provides you a PREVIEW to the updates that will be going live July 1, 2009. The FDA provides this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes ‘go live’ and are accepted in MAUDE. It's important to note that on July 1, 2009 - CDRH will begin accepting the updated codes. DO NOT submit these updated codes prior to that time because they will be rejected. Until that time FDA says to continue to use the current Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes specified in this FDA update. The CDRH Event Problem Code initiative results in part, with updates to codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events. 

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FDA and SAEC Release First Data on Genetic Basis of ADEs

• Recommended FDA GMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Updated July 1, 2025

The original links broke.

You can still read about the same topic here:

FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events - Pharmaceutical Online

---  the original post follows below  ---

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events. The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions. “We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events. 

Additional Information: 

• For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org. 
• For information on the FDA’s Critical Path Initiative see
  https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiative

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