Root Cause Analysis for Better Deviation Investigations - Onsite Courses - Popular

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

Root Cause Analysis for Better Deviation Investigations - Live onsite GMP & QSR training

Don't miss this popular course. This cGMP & QSR training class can be taught at the location of your choice, as a client on-site in-house training.

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'

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

Return to SkillsPlus International Info Blog - Home

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

Additional Keywords: affordable, cGMP, class, compliance, device, drug,energizing, engaging, exciting, FDA, GMP, interactive, manufacturer, medical, pharmaceutical, QSR, SkillsPlus, training

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Live Onsite QSR Training - Olympics for Medical Device Manufacturers

Updated January 10, 2025

The "Olympics" course is no longer available.

You might also be interested in:

https://gmpprof.com/cgmp-training-a-new-generation/

---  the original post follows below  ---

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc. is an exciting, energizing, and engaging on-site class that can be held at a client in-house location.

This challenging class takes QSRs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:

1. List the hottest issues in QSR compliance. 
2. Locate items of interest in 21CFR820. 
3. Explain the 21CFR211 rationale for specific 483 observations. 
4. Demonstrate knowledge of common CGMP practices and details. 
5. State the consequences of not following QSR.

For more information:

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

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

Additional Keywords: affordable, class, compliance, course, device, energizing, engaging, exciting, FDA, interactive, manufacturer, medical, QSR, SkillsPlus,

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Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers

Updated December 7, 2021

The live training course referenced in the original post has been discontinued.

You might also be interested in FDA cGMP online courses and programs by SkillsPlus International Inc.

---  the original post follows below  ---

Exciting, energizing, engaging, live client site class held at your location.
Olympics for Pharmaceutical and Biotech Manufacturers - On-site cGMP Training by SkillsPlus International Inc.

This class takes CGMPs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:

1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211. 
3. Explain the 21CFR211 rationale for specific 483 observations. 
4. Demonstrate knowledge of common CGMP practices and details. 
5. State the consequences of not following CGMPs.

For more information:

Olympics for Pharmaceutical and Biotech Manufacturers - On-site cGMP Training by SkillsPlus International Inc.

Additional Keywords: affordable, biotech, cGMP, class, compliance, computer, computer-based training, cosmetics, course,drug,energizing, engaging,exciting, FDA, GMP, instructor, interactive, manufacturer,pharmaceutical,SkillsPlus, training

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• Human Errors - cGMP Training (skillsplusinfo.blogspot.com)
• Root Cause Analysis - cGMP Training Class (skillsplusinfo.blogspot.com)

cGMP QSR On Site Classes - The Benefits

Updated May 23, 2021

The COVID-19 pandemic continues.

You might also be interested in our FDA CGMP online training - highly regarded FDA GMP online training classes provided by SkillsPlus International Inc.

---  original post follows below  ---

On-site training is the perfect choice for companies that need to train groups of employees.

Onsite Training Benefits:

1. You get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
2. You'll be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
3. You can ensure knowledge & skills transfer from classroom to workplace. 
4. You can minimize employee time away from the office or production line. 

Taking advantage of onsite training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Call our master trainer, Allan Dewes, to arrange your next client site class, (415) 948-5220.

You might also be interested in:  FDA cGMP QSR GMP training course catalog by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts website

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