Pharmaceutical Production Batch Record Review
22 March 2010 - 23 March 2010
Presented by: The Center for Professional Innovation & Education   -   Location: Costa Mesa, CA USA
Contact: Michael Roberts  info@cfpie.com -  610-688-1708    http://www.cfpie.com/showitem.aspx?productid=058&source=gxp

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Upon completion of this course, attendees will gain a clear understanding of the batch record review expectations of regulatory agencies and discover the elements of an effective batch record reviewer training program. Participants will learn how to prepare for a technical review of batch records, as well as how to measure the effectiveness of the review process. In addition to recognizing what to do when a batch fails to meet specifications (deviations), how to determine deviation cause, and corrective and preventive action(s) (CAPA), learners will see the benefits of a working relationship between production and quality reviewers.