Advanced cGMP Training - Root Cause Analysis & Deviation Investigation Reports

Updated June 29, 2020

You asked for it, and we've delivered!

Root Cause Analysis and Investigation Report Writing - an 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.


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.

Pricing | Questions

• If you have questions, call us: (415) 948-5220 

- - -  original post follows below  - - -

Advanced cGMP Training

Advanced GMP Training - Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong cause (for example, a "false" 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 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. 

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

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.

 

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

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Stop Blaming The Same Old "False" Root Causes

Updated May 19, 2022

Now offered as an online training program!

View advanced cGMP training courses taught by SkillsPlus International Inc.

---  the original post follows below  ---

Pinpointing the wrong cause (for example, a "false" 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 courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

.

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

1. Root Cause Analysis for Better Investigations, and
2. Deviation Investigation Reports

- - - FIRST - - -

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

"Purpose:

• To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

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

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

- - - SECOND - - -

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

Purpose:

• To use the data collected in an investigation to write a report and answer management and FDA questions.

 Objectives 

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

 About the Class

1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
4. The optional final exam is approximately 25 questions.
5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
6. This class can accommodate up to 12 people.
7. Duration: 8 hours as a minimum.

For more information:

• Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
• Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Human Errors: Overcoming the Challenges - Onsite cGMP & QSR training

Human Errors: Overcoming the Challenges - live on-site cGMP & QSR training by SkillsPlus International Inc.

Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.

Purpose:
This class teaches how to overcome human errors as a root cause to deviations.

Objectives:  upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.

Topics Covered:

• Overview of 483 observations
• Psychology of human failures
• Investigating human errors
• Preventing human errors

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Deviation Investigation Reports - Live onsite cGMP & QSR training class

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

This class is instructor-led, and is taught at client manufacturing plant locations.

Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.

Objectives:
Upon class completion, students will be able to:

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

Class Topics:

• Incident description 
• Investigations and affected materials 
• Deviation investigations 
• Corrections (path forward) 
• Corrective actions 
• Preventive actions 
• Background information

For more information, visit:

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc. 

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Additional Keywords: cGMP, GMP, QSR, live,onsite,on-site,in-plant,plant,instructor-led,training,class, course, FDA, deviation, investigation,reports, CAPA, SkillsPlus

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Root Cause Analysis for Better Investigations - Live onsite cGMP & QSR training class

Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Learn how to conduct better investigations and address CAPA regulatory requirements.  This is an instructor-led live training class, taught on-site at client locations.

Purpose of this live class: 

• Teaches students how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

Objectives for this onsite training: 
     Upon course completion, students will be able to . . .

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

Course topics include: 

• Deviation statement 
• Deviation investigation 
• Root cause analysis 
• Corrective actions 
• Preventive actions 
• Risk analysis 
• Metrics 

For more course information: 
Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
Additional Keywords: biotech, cGMP, class, compliance, course, device, drug, FDA, GMP, instructor, interactive, International, manufacturer, medical, pharmaceutical, QSR, seminar, SkillsPlus, training

Related articles

• 2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc. (skillsplusinfo.blogspot.com)
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Deviation Investigation Reports - Training Class

Updated June 3, 2020

You might also be interested in:

Root Cause Analysis and Investigation Report Writing - Online Self-Study

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.

Learn more and buy:  Root Cause Analysis and Investigation Report Writing - Online Self-Study (by SkillsPlus International Inc.)


- - -  original post follows below  - - -

GMP Training - Deviation Investigation Reports - cGMP Training

Many FDA observations are caused by failures in deviation management and CAPA.

We can help you in this area, through this course:
Deviation Investigation Reports - a SkillsPlus Intl Inc. training class

This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions.

After completing the class, students will be able to:

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

This class is energizing and exciting, and uses the following teaching approaches:

• In-house deviation reports will be used to demonstrate and practice the skills and principles of this class. 
• This course is best taught in a computer lab. We can ship computer labs to your site if needed. 
• This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

Root Cause Analysis - cGMP Training Class

Learn how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Root Cause Analysis for Better Investigations is a live training class. Upon course completion, students will be able to:

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

In-house projects will be used to demonstrate and practice the skills and principles of this class.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

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