Batch Record Review
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We also recommend: [Procedure Writing for Greater Process Control] [Auditing: Internal and External Customers and Supplies]

 

Faster Product Release Through Efficient Batch Record Review

 

 

Purpose

To be able to competently review batch records to identify errors and issues.

 

Objectives  

   1.   To 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.

About the Class

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

  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 as a minimum. Depending on the project selected, this class may take several days.

Topics

 

Introduction

1.    Heard on the street

2.   CGMP Regulation review

 

US & EU Requirements and Regulatory Expectations

1.   Identify the regulation requirements

2.   Activity: Identify the regulations requirements

 

Best Practices

1.   Forward

2.   Reverse

3.   Calculation

4.   Repeat

 

BPR Regulations Background

 

BPR Audit Items: Skills Practice

1.   Date sequence

2.   Time sequence

3.   Calculations

4.   Rounding

5.   Estimating

6.   Estimates

7.   Entries

8.   Deviations and path forward

 

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Wrap Up

 

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

 

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

© 1991-2015 SkillsPlus International Inc. 

 


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