FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act).

The SSM will use risk factors consistent with section 510 of the FD&C Act, which identifies specific risk factors and allows FDA to determine additional ones, including: “a) The compliance history of the establishment. b) The record, history, and nature of recalls linked to the establishment. c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.””

Read the full source article: FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

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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

Cut Training Costs With Online Learning – eLearning Industry

However …   Just like classroom training, online learning requires engagement at every level of the process. From upper management down to the learners themselves—there has to be some kind of engagement strategy in place. Without this high level of engagement, your training programme is doomed to failure. This means that your training’s return on investment is reliant on the amount of effort you put into effectively engaging your staff with their own self-development.”

Read the full article. Source: Cut Training Costs With 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

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

Free cGMP Tip on Root Cause Analysis (RCA)

Free cGMP tip on RCA

Free GMP Tip for Root Cause Analysis

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 –

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

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

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

Root Cause Analysis: cGMP Training

 

Online self-study course - Root Cause - Investigation Reports

Online self-study course – Root Cause – Investigation Reports

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 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 –

GMP 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

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GMP Training – Courses taught by SkillsPlus Intl Inc.


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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