Top Reasons In-Person GMP Training Can Be Best

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

Call SkillsPlus International Inc. for live on-site in-person cGMP training that's:

Flexible, & Interactive

• You get to: pick the date, time, & location; adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location. 
• In-person training engages students. With the right instructor, on-site training: encourages interaction according to class size and level of training, ensures consistent messages, fosters team building, offers real-time help & support, and provides the important “human touch” (which is often missing in technology-based training). 
• Group interaction enhances learning. Employees learn from one another as well as from the trainer. The group setting also teaches employees how to interact with one another in a professional, productive, cooperative way, which is something that other forms of training often don’t provide. 

 Customized For Your Needs

• Your training needs are addressed. Training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
• Confidential issues can be covered. Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 

 A Great Value

• You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice right on the spot, and training that is engaging & fun.

 Take The Next Step

• Call us:  (415) 948-5220
• E-mail us:  Send E-Mail
• Visit our website:  SkillsPlus Intl Inc. cGMP Training Courses

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

Some people use the following descriptors to talk about live training: onsite, on-site, live, in person, in-person, customized, train more people, live classroom, person to person, face to face, instructor led, instructor-led, synchronous, traditional, personalized,in-class, conventional, classroom-based, live class, interactive teaching, regular classes, classroom training, real classroom, ILT, and instructor led training. 

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NEW! - - cGMP Training - - 2015 On-Site Course Catalog - - by SkillsPlus Intl Inc.

Updated December 16, 2017

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

- -   original post follows below   - -

Start planning your GMP training for 2015.

Get some ideas here, by viewing SkillsPlus Intl Inc.'s new 2015 on-site course catalog of GMP training (PDF).

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FDA Inspection - Tips by the FDAzilla Blog

A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

'via Blog this'


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The Exemptee Institute
The Designated Representative Institute

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GMP Master Training Plans - Free Tips (Video)

Watch this video for free tips on GXP, QSR, and GMP Master Training Plans.

 

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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'

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

FDA rethinking food inspections

I wonder what Upton Sinclair would say about the state of current affairs.

FDA rethinking food inspections - DailyHerald.com:

"The surge in imports has also increased the chances of contamination in foods regulated by the FDA. About 80 percent of seafood, 50 percent of fresh fruits and 20 percent of fresh vegetables are imported.

Despite the mounting threats, the FDA and its contractors inspected only 6 percent of the 421,000 domestic and foreign facilities under its watch in 2010, according to the most recent figures. Inspections account for the full-time work of just 1,000 employees. But if a site is linked to an outbreak of illness, inspectors and FDA scientists descend on it, sometimes staying put for weeks.

Under the food-safety bill enacted last year, food companies must adopt plans to spot and prevent hazards. The law also mandates more frequent inspections. For instance, plants that produce or process high-risk foods, including foods connected to previous outbreaks, must be inspected by 2015 and every three years thereafter."

'via Blog this'

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Knock, Knock, FDA Calling

This is a nice article with a nutritional supplement twist to it.

Knock, Knock, FDA Calling - Slowtwitch.com:

"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."

'via Blog this'

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How much GMP training is “enough”?

• Advanced FDA GMP online training courses & programs offered by SkillsPlus International Inc.

GMP Coaching, How much GMP training is “enough”? Fair...:

"Listen, lack of documented GMP training has been one of the most common FDA Inspection findings so far. “Documented” Training? Yes, the company must have an updated list on file of all training received by every employee.  Expect an FDA inspector to ask to see your training log during the course of the inspection (good reason to make employee GMP Training your top priority) If you don’t keep your training log up to date, the FDA will say that the training never happened. That’s their approach, so be ready."

'via Blog this'

Good points above.  Some training experts might suggest anything from 4-8 hours of training a year to meet "enough."  Also consider, if the company has more deviations, or 483 observations, then that might suggest the need for even more training hours.

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New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:

Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)

'via Blog this'

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

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Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."

A nice, quick and easy primer on 483s.

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Nizoral Shampoo Available Again - I'm thrilled!

Woo-hoo!  After a very long wait, Nizoral Shampoo is back on store shelves.

The manufacturer has been is blaming a switch in manufacturing facilities.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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The Free GMP Countdown - A Few More Weeks Left

• People also ask about 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
  

Updated February 8, 2021

Links in the original post broke.

People also ask about:

Inspection Observations - FDA.gov

- - -  original post follows below  - - -

It's not too late.

SkillsPlus International Inc. is winding down their free GMP countdown. Check it out!

Just navigate to the SkillsPlus International Inc. website, and click on one of the numbered links under the left-side heading of GMP Top 20 Observations Countdown.

Happy reading!

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Win A Free FDA GMP Poster!

• FDA GMP Online Training - people speak highly of CGMP online training courses delivered by SkillsPlus International Inc. (a trusted cGMP compliance training provider).

Updated May 6, 2016

NOTE:  The GMP posters, mentioned below, have been discontinued.

-  -  -

If you're responsible for QA, GMP training, or just trying to keep some key messages in front of your employees, then this is for you.

SkillsPlus International Inc. recently announced the release of a new product line, "a full and yet growing line of GMP Good Manufacturing Practice and QSR Quality System Regulation posters," that can be found on the Skillsplus Motivational Items page.

Just to sweeten up the pot, they've also just announced a SkillsPlus - Register for a drawing to win a free GMP poster of your choice.

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cGMP Posters

• FDA cGMP QSR GMP Training - online training courses

Updated 8/5/2015:

GMP posters by SkillsPlus International Inc. are no longer available.

- - - -  Original Post below - - - -

If you're looking to make your GMP training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

Folks have been clamoring for more GMP-related posters, so it's great to see these new additions to poster offerings. Check it out!

#FDA #GMP #training #cGMP

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C2EO - A fun GMP training game

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

Updated August 26, 2024:

I believe the FDA cGMP training industry continues to evolve.  It's my sense that there are fewer, and fewer companies offering hardcopy board games for cGMP training.

BTW, the C2EO game is no longer available.

- - -  original post follows below  - - - 

Here's a fun game to use, to make your GMP training fun, C2EO. Watch this video teaser for a flavor of the game, "C2EO - a cGMPs training game." The mantra of the game is, "compliance is the rule, knowledge is profit."

Other resources to make GMP training fun:

1. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!

#FDA #GMP #training #cGMP

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