The Best FDA CGMP Training

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

Respected FDA GMP Online Training Courses & Programs

SkillsPlus International Inc., was incorporated in 1991. We offer training services to pharmaceutical and medical device manufacturers.

Initially, we offered live training at client plant sites. Consequently, we traveled all over the world teaching the CGMP regulations. Now as a result of high travel expenses, the risk of COVID-19 exposure, and demanding production schedules, we now only offer our CGMP training online. Our training courses with The GMP Professor are designed by course developers with over 40 years of CGMP experience. Furthermore, our company brings to those courses many commonly applied industry practices that may apply to your site as well.

Learn more about our basic and advanced GMP online training courses.

- - -

The Best FDA GMP Online Training Courses & Programs

#FDA #CGMP #GMP best top choice place recommended respected trusted training

CA HMDR Exemptee Training - The Best Course Around

• Buy Now! - California HMDR Exemptee license training certification course

Updated June 10, 2026

We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.

SkillsPlus International Inc.'s California Exemptee Training Certification Course is accepted by the California Department of Public Health (Food & Drug Branch)

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) providers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee Training Certification Course,  provides information specific to the California Exemptee certification course.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by, and meets the training requirements of, the CA Department of Public Health, and covers:

• California Code of Regulations 
• Business and Professions Code 
• Prescription Drug Laws 
• Controlled Substances 
• USP Storage Conditions 
• Health and Safety Code 

Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

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What Is A Pharmacy Designated Representative?

• California Designated Representative online training courses. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
• Buy a California Designated Representative course now, for:
        Wholesalers | 3PL | Reverse Distributors

Updated June 27, 2018

California Designated Representative Licenses

Now there are more California Designated Representative license types (including, but not limited to):

• California Designated Representative - Wholesaler
• California Designated Representative - 3PL (third-party logistics provider)
• California Designated Representative - Reverse Distributor

If you're applying for any one of these licenses, you might be interested in the following training courses. Successful completion earns a training affidavit (accepted by the California Board of Pharmacy):

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

- -  the original post follows below  - -

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.

SkillsPlus International Inc. offers designated representative training for California and Florida, so you might be interested in:

CA Designated Representative online training certification - for drug wholesalers

FL Designated Representative online exam preparation - for drug wholesalers

The Designated Representative and Exemptee Blog

CA Home Medical Device Retailer (HMDR) Exemptee online CBT training certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog

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QSR and GMP Training Online - Classes by SkillsPlus Intl Inc

Online training gets a bad rap, because there's so much bad stuff out there. There's better training out there!

SkillsPlus International Inc. knows that you expect: 

• online classes that can be taken when you want, 24 x 7
• online classes that avoid travel and hotel costs associated with live training

Check out SkillsPlus International Inc. online training.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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Energizing Online GMP-QSR Training

Image via WikipediaOnline training gets a bad rap, because there's so much bad stuff out there. Don't settle for simple page turners, or slides of boring content.  ... there's better training out there!

Our SkillsPlus International Inc. online training offerings are:

• engaging
• energizing
• exciting

SkillsPlus knows that you expect something social, movie interactive, and NOT BORING!  

Check out SkillsPlus International Inc. online training.

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• Online GMP Training - 21 CFR 820: Essential Elements (skillsplusinfo.blogspot.com)
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Our New Home Page - SkillsPlus Intl Inc.

Never stand still.

We've been updating the SkillsPlus International Inc. home page.

The revamp is intended to make it easier for you to navigate to the products or services that you need.

Did we hit the mark?

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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Select e-Learning That Is Pure, Safe and Effective

Buy Now! |  Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

Selecting an online e-Learning course is really rather simple.

1. Identify the course you really need. An Internet search is a great way to learn what is offered.
2. If they boast about being the least expensive, remember that you get what you pay for. The best business advice I ever got from one of my accountants was, never purchase cheap.
3. Compare the objectives of each course versus your requirements.
4. Call the vendor and ask if there is a handout. If not, begin to wonder if the vendor is afraid that the lesson content may not be accurate and not stand up to a critical review.
5. Ask to see a preview of the course. If they do not offer a free preview, question what they are hiding. Be concerned that you will be paying a lot of money to read a book on your computer screen.

Demand more!

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

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An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity

• People think highly of FDA GMP Online Training - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

I have taken many e-learning courses over many years.

Recently I purchased an e-learning course that really needed to carry a black box warning: Caution this course may be… After purchasing the class I signed in and after some struggling I finally found the first lesson. I clicked the link that said “start.” Well it did, sort of. A PowerPoint slide popped up. Now, I like PowerPoint if done well. However, this slide was full of text so small that I could not read it except by switching to my large screen monitor. There were two paragraphs of text. Now I must admit that I am getting a little older and perhaps the eye glasses need an update. So I waited for something to happen. I waited and waited, until I realized this was it. Read the text baby. So read I did, clicked continued, and finally got to the quiz. While taking the quiz, I wanted to review some content. No, that was not allowed. I responded to the questions the best that I could. If I missed the answer, the only feedback I got was, Incorrect!.

After one lesson I decided that there had to be a better way to learn. I found someone who offered the course in a true online e-learning environment.

Watch tomorrow’s blog to learn how to choose an e-learning provider.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

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Not All E-learning Is The Same

Everybody wants to offer online e-learning solutions for their staff training and development needs. But not all e-learning is the same. E-learning should go beyond reading a book on a computer screen. Honestly, if I am going to read the words on a page I would rather be under a fluffy blanket, and be curled up on the couch with a pot of hot tea and some butter cookies. E-learning should make full use of the technology of the computer.

• I want the instructor to talk to me, preferably, on the screen.
• Add some pictures, or better yet, add some live action video and animation.
• Provide some interaction to keep me fully engaged and challenged.
• Provide a handout to go along with the course so I can use that as a memory jogger after I have completed the course.

1. E-learning developers, challenge yourself to go beyond republishing the text book on the computer screen.
2. E-learning purchasers, demand more from your providers.

Watch for tomorrow’s post for an e-learning black box warning.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus Intl Inc.

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PDA FDA - Interesting Manufacturer Statistics

At the recent international PDA/FDA meeting, some very interesting statistics were shared. Drug products are manufactured in over 130 countries. In those 130 countries, there are over 300,000 manufacturers. Those manufacturers work through 130,000 importers. It is no surprise that the FDA requires drug manufacturers to audit suppliers and assure that the plant shown is the plant that will manufacturer the drug product. The FDA wants to make sure that there are no "shadow plants" being operated out of CGMP compliance.

To learn more about current GMP rules, visit our website:

SkillsPlus International Inc. - cGMP Compliance Training Experts

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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• Ready For Drug Pedigree Rules? (skillsplusinfo.blogspot.com)

Ready For Drug Pedigree Rules?

Updated November 10, 2022

The original post didn't age well.

You might also be interested in:

• Board-approved California Designated Representative courses: 

• Wholesaler Training Course 

• 3PL Training Course 

• Reverse Distributor Training Course

---  the original post follows below  ---

I recently attended a conference that included representatives from the European, Asian, and U.S. regulatory agencies. At that meeting there was much discussion around pedigree rules. Some of the concerns expressed begin with importing drugs and bulk actives (now called active pharmaceutical ingredients (APIs)). At this level, manufacturers are required to qualify supplies. This means that a manufacturer must actually visit the API manufacturing site to assure themselves, and the public, that the production facility shown to the auditor is the actual site of manufacture, and that there is no "shadow site" where the real work takes place. Internationally, there are different approaches to the pedigree. In Europe there is exploration with a "book ends" approach. This approach requires the manufacturer to issue the initial pedigree. The next pedigree touchpoint is at the pharmacy when the product is dispensed to the patient. The thinking is that if the product is moving between known distribution channels, then the product is protected. The U.S. requirement is to document every change in ownership. This means that every touchpoint is documented. Yes, regulators in Europe realize that this approach probably provides better assurance of the supply chain. However, they are also concerned about how much work to pass on to the smaller distributors who may not be staffed for this level of documentation. Learn more about e-Pedigree in our online computer-based training (CBT) courses:

• CA Designated Representative Certification Course by SkillsPlus International Inc.
• FL Designated Representative Training Course by SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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FL Certified Designated Representative - Use The Most Current CIB

• Online Florida Certified Designated Representative Training Course - CDR Resource Center Training Solutions

FL CDR - Caution - Use the most current CIB | Designated Representative and Exemptee: 'via Blog this'

- - - - -

Updated May 29, 2026

Florida Certified Designated Representative Candidate Information Booklet (CDR CIB)

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. Here's how to find it.

Go to the home page of the Florida Department of Business & Professional Regulation:
http://www.myfloridalicense.com/dbpr/

In the search box, enter "candidate information booklets."  Choose English. Then click "DDC – Certified Designated Representative."

- - -  original post follows below  - - -

We continue to see two versions of the Florida Certified Designated Representative (CDR) Candidate Information Booklet (CIB) out on the internet.

Make sure you are looking at the most current version of the CIB. There's an older October 2010 version floating around. At the time of this post, there's a more current version, March 2011 that's been published.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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e-Pedigree - CA Board of Pharmacy

• California Board of Pharmacy Designated Representative Training Courses  |  by SkillsPlus International Inc.
• Register for an online course now:
• California Designated Rep Wholesaler online training course 
• California Designated Representative 3PL online training course 
• California Designated Rep Reverse Distributor training course   
• California HMDR Exemptee online training certification course

Updated August 30, 2020

You might also be interested in:  Epedigree - Wikipedia

- - -  the original post follows below  - - -

We'll be attending the Sept 7th CA Board of Pharmacy meeting, where one of the agenda items is e-Pedigree ...

CA State Board of Pharmacy - Board and Committee Meeting Agendas and Materials

Updated 12/6/2011:
The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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Florida Certified Designated Representative Glossary Gadget

Updated June 7, 2021

The glossary widget is no longer available.

People also look for Florida Certified Designated Representative training for wholesalers by CDR Resource Center. Learn more today. Florida Certified Designated Representative (CDR) laws and rules examination preparation. Consulting expertise in prescription drug regulations and wholesale distribution compliance. State licensing support.

---  the original post follows below  ---

Are you studying for the Florida Certified Designated Representative (FL CDR) exam? Then use our free Florida Certified Designated Representative glossary widget (by SkillsPlus International Inc.) to search for terms and definitions. The previous hyperlink is provided because this blog page might limit how much of the widget to display. 

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CA HMDR Exemptee - Online Training and Certification

Exemptee Certification for California Home Medical Device Retailer (HMDR) - Buy Now!

This training program is intended for employees that must meet the required knowledge and training mandated by California Health and Safety Code and the associated Home Medical Device Retailer (HMDR) Licensing Program. The CA HMDR Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.

Upon successful completion of this web-based course, you'll submit your request to us for training documentation (that prompts us to complete and mail your Certificate of Completion).

California Home Medical Device Retailer (HMDR) FAQs

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California Designated Representative Training Course for Wholesalers - Very Popular

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

People also search for our:  3PL Course | Reverse Distributor Course

Learn more about our very popular online training course:
California Designated Representative Wholesaler Training by SkillsPlus International Inc.

You need to take this online training course, because it's so convenient!

1. It's available to you 24/7, anytime you want.
2. It's online computer-based training that you can take in the comfort of your home or office
3. There's no need for you to travel!

Learn the requirements of a Designated Representative for the State of California. This class meets the requirements for the State of California Designated Representative. This is an on-line self-study pre-recorded presentation with animation and text. Each presentation is followed by the final exam for that section of the class. This class allows you to study from the convenience of your home or office.

Simple FAQs about this training course

Enroll now - California Designated Representative Wholesaler Certification Class by SkillsPlus International Inc.

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