Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP

The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.  I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison.  The guidance is structured in a Q&A format with a total of 18 questions.  This guidance focuses heavily on identifying and citing the predicate rules as they apply to electronic records and data integrity, and for this it is an excellent reference.  In my opinion, though, the excessive citation of regulations detracts from the content and provides little insight into FDA’s intent and actual expectations in this area.

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Open Position

Open Position at FDAzilla: Sales Administrator

Sales Administrator 

Our Company

FDAzilla is a fast-growing data analytics company that provides documents and data services to FDA-regulated companies in the pharmaceutical, medical drug and consulting industries. Our team is growing to meet the increasing demand for our services. We are seeking a sales administrator to handle the day-to-day administrative needs, sales support, customers service and management support. Someone who is analytical, detail-oriented, a team player, customer-focused, and can multi-task. This is part-time position (15-20 hours a week) with the opportunity to become full-time. Work from home.

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