Thursday, October 29, 2015

Root Cause Analysis For Better Deviation Investigations - Our Most Popular cGMP Training Workshop

A GMP Training Workshop - Root Cause Analysis For Better Deviation Investigations

Still true after so many years . . . One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process.

In our onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools.

This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop

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

Tuesday, October 27, 2015

FDA Law Blog: Do You Really Want to Be An Executive In An FDA-Regulated Company?

Read the full article: FDA Law Blog: Do You Really Want to Be An Executive In An FDA-Regulated Company?:

"Appropriate to the forum, he focused on the industries regulated by FDA.  The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge."

'via Blog this'

You might also be interested in this course for cGMP leadership and top management:
Executive Session: What Leadership Needs to Know - GMP Training by SkillsPlus Intl Inc.  

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

Tuesday, October 20, 2015

GMP Training Tips For Modern Learners


cGMP Training - Free Tips For Training Modern Learners

GMP trainers need to be ready for the students of today.

Here are a few training strategy tips for teaching "modern learners."

  • They've got so much to do, they're pulled in many directions, and they can't pay attention to you - TIP:  Craft topics & course titles that are truly useful and valuable to these students. Design courses that are shorter, concise, and to the point. 
  • They're glued to their devices, constantly pinged & pinging - TIP: Grab and keep their attention through interaction and activities.
  • They absorb information quickly - TIP: Try to share information visually and graphically for better recall.

Need more help? Then call Allan Dewes (principal trainer at SkillsPlus Intl Inc.) because of his:

  1. established track record (working with myriad pharma-biotech clients)
  2. subject matter expertise (cGMPs, QSR, and more)
  3. mastery of the classroom and students

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

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

Thursday, October 15, 2015

Plan Now For Next Year - Choose SkillsPlus Intl Inc QSR & GMP Training

The new year is coming - Choose SkillsPlus International Inc. cGMP training & QSR training now!

Book early to reserve your preferred dates.

Select our most popular courses (always customized for you):
  • GMP/QSR Essentials
  • Root Cause Analysis for Better Investigations
  • Writing Deviation Investigation Reports
  • Advanced Deviation Investigation Facilitation
  • Deviation Investigation: One-on-One Coaching
  • Understanding Human Errors
  • Qualstar: A GMP/QSR Simulation
Take the next step:

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

Friday, October 2, 2015

Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog


Read the entire article: FDA Law Blog: Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections:

"Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around.  But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities."

'via Blog this'

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

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

Thursday, October 1, 2015

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

Allan Dewes - President of SkillsPlus International Inc.
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;


- - -  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

FDA will destroy banned imported drugs - Modern Healthcare

Read the full article: FDA will destroy banned imported drugs - Modern Healthcare Modern Healthcare business news, research, data and events:

"Federal regulators will begin destroying some medications that can't be imported into the U.S.​ because of quality concerns.

Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less. "

'via Blog this'

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