2014 GMP Training Ideas - Deviation Investigation Report Writing Workshop

483 Observation Gotchas!

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic. Learn More About the SkillsPlus Investigation Report Writing Clinic

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered. Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more! If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic! Examine The SkillsPlus Investigation Report Writing Clinic Outline

Allan Dewes, President. About Your Instructor Allan Dewes Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document. Email today to request a quotation

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

2014 GMP Training Ideas - Root Cause Analysis of Deviations Workshop

2014 GMP Training

Root Cause Analysis of Deviations:

This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.

Tools addressed in this very popular workshop:
1. 5-Whys In-Depth Map
2. Sequence of Events
3. Distinctions
4. Walk-Through Analysis
5. Change Analysis
6. Control Barrier Analysis
7. Fishbone Diagrams and more!

If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!

Follow this link to learn more about our Root Cause Analysis of Deviation Workshop (a GMP training course)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

'via Blog this'

You might also be interested in:
Root Cause Analysis for Better Investigations - Live On-Site Training Course

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA's Top Supplement Issues (drughealth.blogspot.com)

Top 10 - Reasons Why CAPA or Deviation Investigation Systems Fail

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

I ran across this post on The QA Pharm Blog,  The Top Ten Reasons the Deviation Investigation System Fails. It's a good read amongst some other pretty thought-provoking posts.

In a nutshell:

"Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails: . . . "

You might also be interested in:
Root Cause Analysis for Better Investigations by SkillsPlus Intl Inc.

#FDA #GMP #cGMP #training #course #class

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
inShare