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Limited Availability until July 12, 2024
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 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 accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and 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 on 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 the personnel and management, including senior management, in these areas:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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