Faster Product Release Through Efficient Batch Record Review
To be able to competently review batch records to identify errors and issues.
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. 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
BPR Regulations Background
BPR Audit Items: Skills Practice
1. Date sequence
2. Time sequence
8. Deviations and path forward
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 | firstname.lastname@example.org | Fax: 954.566.5225
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