Showing posts with label recommended. Show all posts
Showing posts with label recommended. Show all posts

Tuesday, July 2, 2024

Popular cGMP Online Training Courses Updated

Popular Training Classes Updated!

Our most popular cGMP online training programs have been updated: 1) 21 CFR 211: Pure, Safe and Effective – Overview of 21 CFR 211, and 2) Proper Documentation Practices – 21 CFR 211 – Subpart J. 

Here's what a recent student says, "Awesome! Great job with the new course, it is much easier to navigate, and has a much better look and feel to it!"

Learn more about these specific courses, and more, or contact Jennifer Payne - SkillsPlus International Inc. by email.

Thursday, December 30, 2021

The Best FDA CGMP Training

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.

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Trusted FDA GMP Online Training Courses & Programs - Image of pharmaceutical glass containers
The Best FDA GMP Online Training Courses & Programs

#FDA #CGMP #GMP best top choice place recommended respected trusted training


Monday, December 13, 2021

California Designated Representative Training Course For 3PL (third-party logistics providers)

Updated May 27, 2026

California Designated Representative Training Course For Third-Party Logistics Providers (3PL)

The Designated Representative-3PL protects the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.

State-approved by the California State Board of Pharmacy. Nearly 10,000 students have taken one of our state license-related training classes!

This course covers all topics specified on the California Designated Representative 3PL license application form.

California Designated Representative Training Course For 3PL - Learn more >>

California Designated Representative Training Course For Third-Party Logistics Providers (3PL). Image of backlit palm trees at sunset on a California ocean beach.
California Designated Representative Training Course For 3PL (third-party logistics providers).
Enroll now!

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

Wednesday, April 1, 2020

The Most Popular GMP Courses Taught By SkillsPlus International Inc.

SkillsPlus International Inc. was originally incorporated in 1991. While serving the needs of over 500 clients and customers world-wide, it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Allan Dewes, President of SkillsPlus International Inc., possesses over 30 years experience in identifying training needs, and creating and delivering practical, cost-effective training solutions for CGMP, GCP, GLP, QSR, management, and supervisory development.  Mr. Dewes and his training team facilitate classes for all levels of the organization.  

What follows below is a small selection of our most popular cGMP training courses.


Root Cause Analysis & Deviation Investigation Report Writing


You asked for it, so we delivered!

The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.

Pricing | Questions? - Call us (415) 948-5220


About The Coaching Option (an advanced option) 


This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.




GMP Trainer Awareness, Certification, and Master Trainer Courses


This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

Pricing | Questions? - Call us (415) 948-5220

How This Course Is Implemented


This course is implemented in three phases: Awareness, Certification, and Master Trainer. This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.

GMP Trainer Awareness – Students view presentations covering the course objectives below.

GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.

GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

In this course, you will learn how to:
  • Apply a Participant Centered Approach to training
  • Write course objectives
  • Development a course assessment
  • Describe the difference between ice breakers and activities
  • Describe and develop ice breakers for a class
  • Describe and develop activities for a class
  • Explain the role of the instructor during activities
  • Develop an activity debriefing strategy
  • Describe various strategies for forming groups
  • Design a course presentation
  • Identify and demonstrate effective presentation skills
  • Develop stories for a class and how to deliver the story
  • Develop discussion questions
  • Develop and implement discussion follow-up strategies
  • Demonstrate the management of disruptive behavior
  • Identify the elements of a course assessment validation plan
  • Identify the elements of a course evaluation form
  • Develop a course evaluation form



GMP eLearning - Online  Courses


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


Ask yourself these three questions:

  1. Do you need to conduct CGMP Training on a limited budget? 
  2. Do you want employees to learn the CGMPs from an expert using real examples? 
  3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

  • 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
  • Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
  • Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
  • Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
  • Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
  • Plan to Production - Part F. Review the requirements for production process controls and validation.
  • Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
  • Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
  • Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

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

 

Saturday, January 2, 2016

F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times


Read the full article: F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times:

"In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and a passion to fight the disease that patient advocates thought he lacked."

'via Blog this'

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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'

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP 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

Wednesday, March 6, 2013

In-Plant On-Site GMP Training & QSR Training Courses

Updated March 10, 2021

Given the COVID-19 pandemic, people are also searching for CGMP online training courses:

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We offer onsite, in-plant GMP training & QSR training courses.

If you've got training needs, we've got the courses and classes for you!
  1. Our live classes span QSR and cGMPs, and more! 
  2. We're training experts with experience! 
  3. Avoid boring courses. Students love our exciting, energizing, and engaging classes! 
Learn more about our training offerings that can be delivered at the location of your choice:
Live, in-plant, on-site, GMP training & QSR training courses taught by SkillsPlus Intl Inc.

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Monday, July 2, 2012

Highly Recommended QSR & GMP Trainer Certification

Updated June 12, 2025


This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

Questions? Call us: (415) 948-5220

- - -  original post follows below  - - -

GMP & QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

For more details, check-out the brochure: CGMP/QSR Trainer Certification Program (PDF)

To register for the class: Register for the CGMP/QSR Trainer Certification Program

Public Seminar Schedule and Course Description:  SkillPlus International Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website


Tuesday, May 29, 2012

The Best GMP Training - Look No Further!

Look no further!

SkillsPlus International Inc. students, trainees, and clients all agree, we're the best.

Learn more about SkillsPlus International Inc. industry leading GMP online courses, and programs.

Year after year, SkillsPlus QSR & GMP training and trainers are described as . . .
  • the best
  • respected
  • popular
  • recommended
  • terrific
  • tops
  • excellent
  • superior
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  • superb 
  • unequaled
  • unparalleled
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  • informative
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  • exciting
  • entertaining
  • beyond compare 
  • finest
  • first-class
  • foremost
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  • outstanding
  • peerless 
  • second to none
  • super 
  • desirable
  • choice
  • choicest
  • number 1
  • premium
  • superlative
  • supreme
  • good
  • very good 
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Monday, January 16, 2012

Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers

Updated November 8, 2022

The links in the original post broke.

You might also be interested in:

---  the original post follows below  ---

Here's one of our popular onsite cGMP training classes:
   Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.

Upon completion of this class, students will be able to:
  1. State the historical development of CGMP regulations. 
  2. Explain the role and function of standard operating procedures. 
  3. Describe the personal role for contamination control. 
  4. Identify the sources of contamination. 
  5. List the common CGMP documentation practices. 
  6. Explain material controls. 
  7. State the common practices of production and process controls. 
  8. Explain the importance of an adequate, appropriate, and sufficient building design. 
  9. State the requirements of equipment design and construction. 
  10. List the requirements for building, and equipment cleaning and maintenance. 
  11. Explain the role of quality assurance. 
  12. Explain the role of quality control.
Learn more about this class:
Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
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