GMP Training - Online Training Courses

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

Updated October 10, 2020

Links broke in the original post.

You might also be interested in:

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

- - -  original post follows below  - - -

 

Plan for cGMP Training 2014!

 2014 is just around the corner! 

1. Do your employees avoid CGMP training, claiming they've heard it all, or
2. Do they resist attending CGMP training because "their" job is never discussed, or
3. Do some employees "drift off" in CGMP training because it is too theoretical?
   
   If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.

Learn More About SkillsPlus
 

 

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

GMP Training Recommended: The Qualstar Simulation

Updated June 12, 2025

The live onsite course is no longer offered.

You might also be interested in online cGMP training courses offered by SkillsPlus International Inc.

---  the original post follows below  ---

Qualstar - A CGMP Simulation:

Designed to teach and to change the culture of companies, so that a focus on quality and compliance is achieved. This competitive simulation is an eye-opener for participant and executive staff observers alike.

Issues addressed in this exciting simulation:
1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations

If this describes some of your issues, then you need to experience Qualstar!

Follow this link to learn more about Qualstar - A cGMP Simulation (a GMP training course)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Using Video In The Classroom - Free GMP and QSR Training Tip

Image via Wikipedia

Using Video In The Classroom - Free GMP and QSR Training Tip | SkillsPlus International Info:

1. "Tell the class what they are going to see and why you want them to see it. 
2. Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD." 
3. Now it's time to turn on the DVD. See our list of SkillsPlus Intl Inc. movies and interactive CBTs 
4. After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog

• Using Video In The Classroom - Free GMP and QSR Training Tip (skillsplusinfo.blogspot.com)

Annual FDA Inspections Summit

• The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

Updated June 5, 2025

The original link broke.

You might also be interested in the Annual FDA Inspections Summit:

https://wcg.swoogo.com/fda-inspections-vsummit

- -  original post follows below  - -

Sixth Annual FDA Inspections Summit:  'via Blog this'

This caught my eye. I'm sharing it because I know that many of you have an interest in FDA inspections.  The Sixth Annual FDA Inspections Summit is scheduled for Tuesday, Oct. 4 - Thursday, Oct. 6, 2011, in Bethesda, MD.

With a quick Google search, the other large event seminar offering an FDA Inspection focus, was this seminar held earlier in the year:

ISPE - The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,”

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

Related articles

• FL Certified Designated Representative - Use The Most Current CIB (skillsplusinfo.blogspot.com)

FDA Launches Website Explaining Food and Drug Regulations

It's a new year, and it's time to think about professional development goals for 2011.  You or your friends, family, or staff, might want to consider learning some of these FDA Basics:

FDA Basics for Industry  or
FDA Basics - Provides Information About FDA and What the Agency Does

Return Home: http://drughealth.blogspot.com/

Dietary Supplement Fact Sheets by NIH Office of Dietary Supplements

Nice source of information about dietary supplements, National Institutes of Health Office of Dietary Supplements Fact Sheets.

According to the NIH ODS:

The Office of Dietary Supplements, a part of the National Institutes of Health, works to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public about the efficacy and safety of dietary supplements in order to foster an enhanced quality of life and health for the U.S. population.

Return Home: http://drughealth.blogspot.com/

FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

Return Home: http://drughealth.blogspot.com/ G

GMP Training - The end is near - I mean 2009!

Yep, the year is coming to a close. If 2009 snuck up on you and you still have some training needs, it's not too late. Arranging some onsite training might be challenging, but it's not too late to identify vendors that offer products and services that you can leverage. For example, buy some modules or materials, so that you can deliver training yourself. Or, locate vendors that offer online delivery of training via CBT (computer based training), so that you don't have to spend an arm and a leg to bring in a trainer on-site. The fastest way to find vendors who can help you, is to use www.google.com and search on "gmp training". 2009 is almost gone, and it's time to start planning your 2010 regulatory training plan. 

Return Home: http://drughealth.blogspot.com/ 

Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

Return Home: http://drughealth.blogspot.com/ 

Free GMP Training Tips - Follow adult learning principles

• FDA cGMP QSR GMP Online Training - by SkillsPlus International Inc, a provider of cGMP online training classes

Updated January 10, 2021

The links in the original post broke.

You might also be interested in:
Mining Publication: Principles of Adult Learning

Strategies For Improving Miners’ Training (PDF)

- - -  the original post follows below  - - -

Are you planning an upcoming GMP training session? If you are, every now and then, it's always a good idea to review the principles of adult learning. Then as you're working out the class curriculum and agenda, you can be sure to pay attention to the major adult learning principles and adjust your plan for training. Training grown-ups is challenging. Having an awareness of the challenges is half the battle.

Free resources about adult learning:

1. Adult Learning Tip 1: Developing a Curriculum
2. Adult learning Tip 2: Understanding Principles - using training of miners as an example
3. Adult learning Tip 3: Applying Principles - using training of miners as an example

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

Courses, classes, workshops, and seminars - FDA QSR GMP cGMP training

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog