cGMP Online Training Courses

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

  • $50 per individual course. Once a course is purchased, you’ll be able to view the course one-time (within 48 hours from the time of purchase).
  • Call us about Annual Global License pricing.
  • Questions? Call us: (415) 948-5220

Online Training Classes Currently Available

  • 21 CFR 211: Pure, Safe and Effective
  • Proper Documentation Practices
  • Your Personal Responsibility
  • Maintaining Compliant Equipment Practices
  • QSR: 21 CFR 820 Quality System Regulations
Online FDA cGMP QSR GMP Training Courses
Online FDA cGMP QSR GMP Training Courses

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

FDA Issues COVID-19 Public Health Emergency Questions and Answers

“FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.”

According to the FDA guidance:

“FDA has issued guidance on how to implement manufacturing process and facility changes; relevant guidances that describe the process for reporting changes to an application can be found in section V., References. The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Office of Regulatory Affairs (ORA) remain fully capable of continuing daily activities, such as application assessments, including facility evaluation and certain inspection activities, while responding to public health needs related to the current COVID-19 pandemic. As this remains an evolving and very dynamic situation, FDA will continue to be flexible and as transparent as possible.”

Citation: refer to the FDA link below

Open this PDF to view the full FDA Guidance: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers – FDA Guidance For Industry

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


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

Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

The Most Popular FDA QSR GMP Training Courses by SkillsPlus Intl Inc.

With the presence of COVID-19, many organizations have shifted their training efforts to online training delivery methods.

You might be very interested in the most popular online training classes offered 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.

Below is a small selection of our most popular online 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.

Fees

  • Basic Course access is $995 per student.
  • Advanced Coaching Option is $800 per student per 4-hour block of coaching time. Time is based on Allan’s actual document review time and preparing feedback. Additional review time segments can be purchased.
  • Special group or classroom rates are available.

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.

Questions?

Call us: (415) 948-5220

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.

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.

  1. GMP Trainer Awareness – Students view presentations covering the course objectives below.
  2. 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.
  3. 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

 

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

GMP eLearning  Online Courses

About Our Online Training Courses

  • $50 per individual course. Once a course is purchased, you’ll be able to view the course one-time (within 48 hours from the time of purchase).
  • Call us about Annual Global License pricing:  (415) 948-5220

Courses Currently Available

  • 21 CFR 211: Pure, Safe, and Effective – This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
  • Documentation Practices – This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments.
  • Equipment and CGMPs – This topic discusses the requirements of 21 CFR211 Subpart D – Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.

Courses Coming Soon

  • Buildings and Facilities
  • Surviving an FDA Inspection
  • Understanding Validation
  • Contamination Control
  • Materials and CGMP
  • Organization and Personnel
  • Production and Process Control
Online FDA cGMP QSR GMP Training Courses
Online FDA cGMP QSR GMP Training Courses – Give us a call:  (415) 948-5220

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

Medical Device Tax Is History After Trump Signs Repeal – BioFlorida

According to the article:

“The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade.

The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again.”

Read the full source article:  Medical Device Tax Is History After Trump Signs Repeal – BioFlorida

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

FDA cGMP QSR GMP Online Training Courses by SkillsPlus Intl Inc.

cGMP, QSR, GMP online training courses taught by SkillsPlus International Inc.

Learn more about our most popular online training courses:

  • Root Cause Analysis and Investigation Report Writing – Online Self-Study
  • GMP Trainer Awareness, Certification, and Master Trainer Course
  • Online e-Learning Courses

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

Classroom Learning Vs. eLearning – elearningindustry

According to the article:

“In this article, we will discuss the basic differences between eLearning and classroom learning based on 4 important factors, such as time, freedom to study a course of one’s own choice, degree of understanding, and cost-effectiveness.”

Source article:   Classroom Learning Vs. eLearning – elearningindustry.com

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

3 Ways To Overcome Resistance To Online Learning – eLearning Industry



“Despite the widespread adoption of technological advances, people still resist online learning. Although we may be quick to point the finger at older generations that did not grow up digitally, the resistance can come from any age group for any number of reasons.

Rather than discuss those reasons, I want to consider how we can overcome the resistance. Three ways I have found effective in practice are: highlighting the benefits, demonstrating the possibilities, and offering training.”

Read the full source article: 3 Ways To Overcome Resistance To Online Learning – eLearning Industry

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

FDA Announces NIPP For Sterile Injectable Drugs



“This New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings. The protocols also include additional questions related to quality culture observed in facilities. The new tool is being applied to our inspectional work related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past. The primary focus of this new tool is to ensure a more streamlined and consistent coverage and reporting of our inspectional activities.”

“These aseptic processing drug inspection protocols for sterile drugs are the first of what we plan to be a series of valuable new inspection protocols covering all dosage forms. As we integrate learnings from these pilots in our field activities, our goal is to have them ready for full implementation within the next two years. These modern tools are a key part of our efforts to protect the health and safety of U.S. patients.”

Read the full FDA Press Announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs – FDA.gov

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

GMP Trainer Awareness, Certification, and Master Trainer Courses

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.

How This Course Is Implemented

This course is implemented in three phases: Awareness, Certification, and Master Trainer.

  1. GMP Trainer Awareness – Students view presentations covering the course objectives below.
  2. 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.
  3. GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

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.

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

Keywords:  trainer certification, train the trainer, T4T, FDA, cGMP, QSR, GMP, training

You might also be interested in:
GMP Training – Courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website