Wednesday, October 12, 2011

Energizing Online GMP-QSR Training

Online education and Financial AidImage 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!  


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SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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Monday, October 10, 2011

Our New Home Page - SkillsPlus Intl Inc.

Never stand still.


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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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

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Wednesday, October 5, 2011

Select e-Learning That Is Pure, Safe and Effective


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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Tuesday, October 4, 2011

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

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.

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

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Monday, October 3, 2011

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.

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

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Monday, September 26, 2011

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:

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Thursday, September 22, 2011

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: 

---  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

Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

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Monday, September 19, 2011

Online GMP Training - 21 CFR 820: Essential Elements

Updated October 28, 2018

The original post didn't age very well.

You might be interested in the current selection of SkillsPlus International Inc's FDA QSR cGMP training courses and workshops

- - -  original post follows below  - - -

Take this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.
This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT
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Monday, September 12, 2011

FL Certified Designated Representative - Use The Most Current CIB



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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Monday, September 5, 2011

e-Pedigree - CA Board of Pharmacy


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 ...




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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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT
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