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Batch Record Review is a critical part of your operations. This practice is both a vital component to your quality efforts, and a global regulatory requirement. Your firm’s production efforts must be carefully documented. Standard Operating Procedures (SOPs), process controls, and deviations all fall under the purview of batch control. If your efforts are clear, concise, and repeatable, then you have nothing to fear. If your batch control documents are difficult to read, sloppy or worse – non-existent – then look forward to a litany of sanctions, recalls, and costly delays.
Most 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 that demonstrate compliance. The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential. This webinar with expert speaker Danielle DeLucy, MS, will analyze each of these necessary elements of the batch record review process.
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