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During this course, you will learn all relevant aspects of the batch record flow from the master to the review. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.
The Batch Record Review is an essential tool for assuring the quality of a pharmaceutical process.
Various regulations and guidelines address this topic for the pharmaceutical industry and it is a very important step before a product can be certified by a Qualified Person. However, over the years, documentation has become more and more extensive and the review can be very time-consuming, also because of complex master documents.
Furthermore, many observations made in inspections relate directly to the review of batch records. This fact clearly demonstrates the importance and challenge of implementing a GMP/FDA-compliant batch record design and review.
Furthermore, many observations made in inspections
relate directly to the review of documents. This fact clearly demonstrates the importance and challenge of implementing a GMP/FDA-compliant Batch Record
During this Education Course, experts will cover all relevant aspects helping you to improve your batch records and their review.
This Education Course is designed for all persons in Production and Quality Units who deal with the design and review of batch documentation in pharmaceutical, biopharmaceutical and API production. It is also addressed to Qualified Persons who want to improve their system of the batch record review.
Three parallel workshops will be conducted in order to deepen the content of the lectures and to discuss practical aspects in detail.
Workshops will be offered on the following topics:
Deviation Management and Failure Investigation as Part of the Batch Record Review
How to optimize your Batch Record Review flow: The way from status quo to an ideal state
Organisation of a Batch Record Review
Each participant will have the opportunity to take part in 2 workshops! Please choose the ones you like to attend when you register for the course.
Regulatory Requirements applying to Batch Record