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

Faster Product Release Through Efficient Batch Record Review - Onsite cGMP & QSR Training Class

Updated March 17, 2023

The batch record review course is no longer available.

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

---  the original post follows below  ---

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

This is a live on-site class. It is instructor-led and taught at the client location of your choice.

Purpose:
This live on-site GMP & QSR training class teaches students how to competently review batch records to identify errors and issues.

Objectives:
Upon course completion, students will be able to:
 1. State the source of batch record requirements for both US and EU
 2. Distinguish between the production and QA batch record review
 3. List best practices in Batch Record Review
 4. Demonstrate at least 5 different batch record review activities.

Topics include:

1. Regulation review 
2. US & EU Requirements and Regulatory Expectations 
3. Best Practices 
4. BPR Regulations Background 
5. BPR Audit Items: Skills Practice 
6. Trending

For more information, visit:

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

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

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Batch Record Review Training - a live cGMP class

• People also prefer online training - FDA CGMP online training courses provided by SkillsPlus International Inc.

Updated August 17, 2022

The batch record review course is no longer available.

You might also be interested in our other cgmp online training programs and courses.

---  the original post follows below  ---

GMP Training - Batch Record Reviewing - cGMP Training

Learn how to review batch records to identify errors and issues.

Faster Product Release Through Efficient Batch Record Review is a live training class. Upon course completion, students will be able to:

1. State the source of batch record requirements for both US and EU 
2. Distinguish between the production and QA batch record review 
3. List best practices in Batch Record Review 
4. Demonstrate at least 5 different batch record review activities

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