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

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

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

Root Cause Analysis and Investigation Report Writing – New! – Online Self-Study Course

You asked for it, so we delivered!

Buy Now! – Root Cause Analysis and Investigation Report Writing – Online Self-Study Course

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.

Here’s what’s covered in the basic class:

Root Cause Analysis

  • GMP Compliance Requirements
  • Deviation Investigation Definitions
  • Deviation Investigation Teams
  • Interviewing and Path Forward
  • Fishbone Diagrams
  • The Five Why’s Map
  • Distinctions
  • Walk-Through-Analysis
  • Change Analysis
  • Understanding Human Errors
  • Control Barriers
  • Product Impact
  • Previous Investigations (Look Back)
  • Immediate Actions
  • Containment
  • Corrections
  • Corrective Actions
  • Preventive Actions
  • Follow-Up and Effectiveness Checks
  • Risk Assessment

Investigation Report Writing

  • Writing Tips
  • Writing the Description of the Event
  • Event Classification Reporting
  • Writing Immediate Actions and Containment
  • Reporting on Previous Investigations
  • Sequence of Events (root cause discussion)
  • Root Cause Summary
  • Writing about Product Impact
  • Reporting on Corrections and CAPA
  • Reporting the Follow-Up and Effectiveness Checks
  • Background Information, Attachments and Referential Information
  • Interim Reports

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.

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.

How To Enroll: 
Buy-Register-Enroll in Root Cause Analysis and Investigation Report Writing – Online Self-Study Course

Certificates: Students who successfully complete all topics will receive a certificate of completion via email from Allan.

Have more Questions: Call Allan at 415.948.5220 or 954.873.7422 or Email at allan.dewes@skillsplusinc.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

Advanced GMP Training – Root Cause Analysis & Deviation Investigation Reports

Advanced GMP Training

Advanced cGMP Training

Updated April 26, 2018

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.

– original post follows below –

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