FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:

• batch failure rate
• right first time, and
• out-of-specification (OOS)/laboratory failure investigation rates"

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

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

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

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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