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

Advanced cGMP Training Courses & Classes

Advanced GMP Training

Advanced GMP Training Workshops & Seminars

SkillsPlus International Inc. offers both advanced and basic GMP training courses and classes. While serving over 350 clients and customers world-wide (in the pharmaceutical, biotech, and medical device industries), it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Do you have an advanced cGMP training need?  Then give us a call to see how we can help you:  (415) 948-5220.


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

#FDA #cGMP #GMP #training #basic #advanced #courses #classes #workshops #seminars

GMP Training | Live - Onsite - In-Person by ...

Allan Dewes - SkillsPlus Intl Inc.

Updated July 16, 2020

The entire world is having to adjust to COVID-19.

If you're finding it difficult to arrange live training, then you'll be interested in online FDA cGMP QSR GMP training courses taught by us, SkillsPlus International Inc;

• FDA GMP QSR cGMP Online Training Courses - presented by SkillsPlus International Inc.

- - -  original post follows below  - - -

cGMP Training | Live - Onsite - In-Person by Allan Dewes, SkillsPlus International Inc.

Explore SkillsPlus Intl Inc. onsite courses that master trainer, Allan Dewes, can teach in-plant, at your site. We always tailor our courses to suit your site's learning needs and environment.

SkillsPlus GMP training is engaging, energetic, and enlightening.

Here's a small sample of what our students have to say ...

Learn more:  SkillsPlus Intl Inc. - FDA QSR GMP Training On-Site Course Catalog (PDF)

#FDA #cGMP #GMP #training #courses #classes

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group

• Respected FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

View the article with multiple links:  GMP News: WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group, an ECA Foundation Interest Group:

"For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products."

'via Blog this'

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Who Offers GMP Training?

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

---  original post follows below  ---

Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call (415) 948-5220.

#FDA #GMP #training #cGMP #courses #classes

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FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing

• FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

Read the full article: FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing:

"Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers."

'via Blog this'

You might also be interested in the following GMP training course:

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

New FDA Guidance to Avoid Overfill of Vials - ECA GMP News

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Updated July 2, 2024;

The original link broke.

People are also asking about:

Moderna asks FDA's permission to add 5 more COVID-19 vaccine doses per vial - Becker's Hospital Review

- - -  the original post follows below  - - -

Read the full article: GMP News: New FDA Guidance to Avoid Overfill of Vials - ECA:

"If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls. Since it is nearly impossible to extract 100 % of the liquid but the dosage has to be correct, nevertheless, vials usually are slightly overfilled. A vial with a dosage of 1 ml might for example contain 1.1 ml. The FDA has two points of concern: on the one hand some manufacturers fill up to much or not enough drug products without sufficiently justifying this which may result in medication errors. On the other hand the leftover of several vials with excess volume could be pooled to obtain a further dose which could lead to microbial problems."

'via Blog this'

View the guidance:
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products - FDA Guidance for Industry (PDF)

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---------

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

FDA launches openFDA to provide easy access to valuable FDA public data

• Respected FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated October 7, 2021

The original link broke.

You can still read about the same topic here:

FDA launches openFDA to provide easy access to valuable FDA public data - WorldPharmaNews

---  the original post follows below  ---

Read the full article: Press Announcements > FDA launches openFDA to provide easy access to valuable FDA public data:

"Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis."

'via Blog this'

Go to: openFDA

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

About Florida Certified Designated Representative (CDR)

Florida Department of Business and Professional Regulation - Certified Designated Representative:

"Drugs, Devices, and Cosmetics Program - Certified Designated Representative: All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."

'via Blog this'

Learn about the FL CDR program at the webpage above. It covers:

• requirements
• application
• certification criteria
• operational requirements
• fees

You might also be interested in:

Florida Designated Representative Study Course: online web training by CDR Resource Center

California Designated Representative Training - for wholesalers, 3PL, reverse distributors

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It's Not Too Late To Spend Your Year-End Training Funds

• FDA GMP Online Training - recommended FDA CGMP online training classes offered by SkillsPlus International Inc.

This year is coming to an end.

Do you still have remaining training funds that you need to spend (or lose!)?

Then check out our training options and offerings on the SkillsPlus International Inc. web site - we're the The Leader in Compliance Training: cGMP, QSR and State Licenses.

You might be especially interested in our catalog of engaging & energizing online computer-based training (CBT) courses.

• avoid the hassle of coordinating a last minute on-site class
• avoid the bother of trying to deal with your trainer's travel expenses, and more
• have students take the online classes by computer, without totally disrupting the production line

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SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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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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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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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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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? (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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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.

21 CFR 820: Essential Elements on the Computer-Based Training page by SkillsPlus International Inc.

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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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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