Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC. a dynamic, innovative quality solutions provider to life science startups and global Fortune 500 organizations who are as passionate as we are about keeping patients safe and delivering quality products.
This 15 hour course is intended to take the mystery out of the batch record review process. The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations. Interactive sessions are included for identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process. Additionally, participants will be able to analyze their company's compliance with these requirements and identify missing elements of the batch review process.
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.
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