Free cGMP Tip on Root Cause Analysis (RCA)

Free cGMP tip on RCA

Free GMP Tip for Root Cause Analysis

Free GMP tip on root cause analysis (RCA)

The FDA says, “Human error is not a root cause.” If your first reflex is blaming human error, it’s time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations – A cGMP QSR GMP Training Course
Deviation Investigation Report Writing – A GMP QSR cGMP Training Workshop

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

Advanced GMP Training – Root Cause Analysis & Deviation Investigation Reports

Advanced GMP Training

Advanced cGMP Training

Advanced GMP Training
Advanced cGMP Training – Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong root cause can result in ineffective immediate, corrective, and preventive actions. Throwing fixes at the wrong things might not fix the problem. Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis. By taking our advanced courses, you’ll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly popular and inter-related courses.

Root Cause Analysis for Better Deviation Investigations: On-site Advanced GMP Training by SkillsPlus International Inc.

Course Objectives:

  • Use tools and techniques to effectively identify the deviation statement
  • Identify the root cause of the deviation.
  • Generate and objectively select the best corrective and preventive actions.
  • Assess the risk of implementing the corrective action and preventive action.
  • Develop a contingency plan to preventive action implementation.
  • Create corrective actions and preventive action metrics.

Deviation Investigation Reports: On-Site Advanced GMP Training by SkillsPlus International Inc.

Course Objectives:

  • Increase investigation report suitability for FDA review.
  • Decrease the number of reports returned by internal reviewers.
  • Write supported deviation statements.
  • Provide a detailed background statement to include related information, investigations, affected materials and references.
  • Document deviation investigation findings.
  • State the root cause with supporting facts.
  • Generate supported, plausible, and defensible corrective actions.
  • Develop effectiveness measures for the corrective actions.
  • Generate realistic preventive actions.
  • Develop effectiveness measures for the preventive actions.
  • Develop a follow up plan for corrective and preventive actions.
  • Write accurate executive summary statements.

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

Introduction To FDA cGMP – A basic GMP course

cGMP basics course

Basic FDA GMP training for new hires and experienced staff.

Situation:  You’ve just hired some new employees, and your seasoned staff need refresher training.

Solution:  Contact SkillsPlus Intl Inc. for their popular basic cGMP course. It’s perfect for introducing and re-introducing essential FDA concepts to all your employees.

Call:  (415) 948-5220

Web:   Essentials for Pharmaceutical Manufacturers 

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

6 Ideas To Help You Create Nano-Learning In Under 15 Minutes  – eLearning Industry

Podium presenter and presentation on screen

“Fast-paced organizations need just-in-time (JIT) learning. Nano or micro-learning gives learning managers a quick and simple way to adapt to the fast-changing needs of their learners. In this article, I’ll show you how to create nano-learning in under 15 minutes.”

Read the full article with tips:  Source: 6 Ideas To Help You Create Nano-Learning In Under 15 Minutes  – eLearning Industry

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

Root Cause Analysis: cGMP Training

Root Cause Analysis Workshop: GMP TrainingGMP Training – Root Cause Analysis Workshop

One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process. In this 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. Allan Dewes (SkillsPlus International Inc.) has taught this course all over the world with exceptional results.

Call Allan Dewes (principal trainer):  (415) 948-5220, or
Learn more:  Root Cause Analysis For Better Investigations by SkillsPlus Intl Inc.

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

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

Top 4 Freeware eLearning Authoring Tools In 2015 – eLearning Industry

Students looking at the same computer screen

“If you are an educator, teacher, author, or designer who is looking for most trusted free-to-use eLearning course authoring tools in 2015, you can try any of the 4 being described below.”

Read the full article with links to the 4 tools: Source: Top 4 Freeware eLearning Authoring Tools In 2015 – eLearning Industry

The 4 authoring tools reviewed are:

  1. EasyGenerator
  2. CourseLab
  3. GLO Maker
  4. SmartBuilder

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

7 Tips To Implement Blended Learning In Corporate Training – eLearning Industry

Students watching a presentation” . . . figuring out how to integrate learning technology tools most effectively can be tricky and time consuming. There are, however, some blended learning best practices you can follow to implement a blended learning program that boosts employees’ performance and gets them excited about using learning technology to their advantage.”

Read the full article to see all the tips – Source: 7 Tips To Implement Blended Learning In Corporate Training – eLearning Industry

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


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

Using Storytelling For Compliance: Why Storytelling Is At The Heart Of Great Compliance Training – eLearning Industry

Smiling children with chin on hands, waiting to hear a story“Learning facts is difficult, but assimilating a story is something that comes naturally to most of us. Read how using storytelling for compliance training helps compliance learners not only absorb information, but also change their behaviors.”

Read the full lesson: Source: Using Storytelling For Compliance: Why Storytelling Is At The Heart Of Great Compliance Training – eLearning Industry

You might also be interested in our:
cGMP Mini-Series Videos – Multimedia you can insert into your GMP training


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

Microlearning Breaks Down Training To Build It Up – eLearning Industry

Colleagues looking at a computer display

“It can be overwhelming to think about restructuring a program, but you can start small. Assess which parts of your curriculum are best suited to becoming bite sized. Rebuild just a portion, changing a few courses in your overall training solution. Or begin building new programs with micro elements.”

Source: Microlearning Breaks Down Training To Build It Up – eLearning Industry

You might also be interested in our:
cGMP Mini-Series Videos – Multimedia you can insert into your GMP training


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

Who Offers GMP Training?

Who offers GMP training? SkillsPlus Intl Inc. does!Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here’s why you need to choose SkillsPlus Intl Inc.:

Expertise – We’ve been delighting clients for more than 20 years. Allan Dewes, President & master trainer, combines his regulatory knowledge and operations experience to meet your needs. He’s personable, an active listener, and a trusted partner to 100s of satisfied domestic & international clients. He helps clients succeed.

Live GMP Training – Leadership and course participants rave about our onsite courses. These popular courses are considered interactive, engaging, relevant, and sometimes fun! Students want to be in our classes, instead of trying to find ways to avoid going to class.

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call Allan Dewes, President & master trainer, (415) 948-5220.

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


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