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A Batch record review is a complicated and often lengthy process. However, a strong review system is essential so all critical processing parameters are properly documented. Learn the fundamentals of batch record reviewing and its necessary elements, in this manual
Regulatory agencies often require firms to have written procedures to document production and process controls. These written procedures are known as batch records, and they in turn require a batch record review process, to demonstrate compliance. Reviewing batch records can be tough work, especially if you do not know what to do at each step. In this manul, our expert researcher will walk you through the subject of batch record reviews, providing crucial information and equipping you with tools which will help you perform your duties better.
You will learn the regulatory requirements for batch record review, and what to look for during a batch record review – good documentation practices, compliance to critical quality attributes and critical processing parameters, etc. You will also learn about a training plan which batch record reviewers must undergo, before they are considered qualified for the job.
How to establish a strong working relationship between production and quality reviewers, how to ensure that production and quality reviewers coincide with their reviews, and more.
Quality Assurance and Batch Record Reviewers, Production Personnel, Production Managers, Compliance Auditors, Manufacturing Management & Scientist, Other professionals who review batch records
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