FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS

Read the full article: FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS:

"FDA spokesperson Lyndsay Meyer confirmed to Focus that the long-planned program alignment for ORA will kick off on 15 May 2017, saying the office "will be moving away from a geographic (regional) management model and align with a commodity-based program structure. All regional food and drug directors (RFDDs), regional directors and regional staff will transition into other positions in ORA.""

'via Blog this'

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FL Certified Designated Representative - Candidate Info Booklet

Updated July 26, 2026

Buy FL CDR training & examination preparation.

Links broke in the original post.

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  - - -

Here's the latest version of the CIB:
State of Florida - Candidate Information Booklet (CIB) for the Certified Designated Representative Laws and Rules Examination - Oct 2011.

Beware, there are older versions out there.

If you're preparing to take the Florida CDR Exam (Certified Designated Representative), make sure you're referencing the latest and most current version of the CIB (candidate information booklet).

While simply Googling, I ran across three different versions of the CIB.  One was the outdated October 2010 version, another was dated March 2011.

Bottomline, be sure you find and reference the most current version of the CIB.

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Energizing Online GMP-QSR Training

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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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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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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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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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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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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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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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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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Overcoming The Documentation Nightmare Course

Updated December 24, 2020

The product referenced in the original post has been discontinued.

You might also be interested in:

FDA GMP QSR cGMP Online Training

FDA GMP QSR cGMP Online Training - popular GMP online training courses provided by SkillsPlus International Inc. 

#FDA #cGMP #GMP #QSR #training

- - -  the original post follows below  - - -

We're listening to you.

  

We've made it a little easier for you to find information and details about our Overcoming the Documentation Nightmare CBT by SkillsPlus International Inc. Consolidated information about the class now appears on its own dedicated page.

If your plant site experiences high documentation deviation rates and needs to drive that rate down, take a look at this computer-based training course. Clear explanations of current documentation rules are provided. Numerous opportunities for students to challenge their knowledge and retention of information keeps students engaged.

This online course was designed for affordability, and quick teaching time, which fits into the training schedules of most sites.

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New - Overcoming the Documentation Nightmare (CBT)

Learn more about this SkillsPlus Intl Inc. computer-based training: Overcoming the Documentation Nightmare