Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive qu...
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FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to...
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Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Product...
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It is important for contract manufacturing operations, whether they are in the cosmetic, drug, or device industries to have a Quality Agreement in place. This webinar will teach you what a Quality Agreeme...
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This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current tw...
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