Regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical and operational process parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
In this introductory training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, key steps for issuance, batch record review, reconciliation, and final QA disposition. Several examples and case studies of best practices will be demonstrated to emphasize how an effective batch record review is conducted based upon current quality/regulatory requirements.
Upon completion of this course, you will be able to:
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This entry-level online training is designed for professionals in the Pharmaceutical, Medical Device and other life science industries.
It will be especially valuable to personnel and management, including senior management, in these areas:
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