October 2013

For Medical Device Companies

Ten Points for Successful Use of TPLC Reports

by Maria Fagan, Regulatory & Quality Solutions LLC

The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to proactively address quality-related issues as early as possible. The TPLC database allows users to search by type of device (product code) and provides a report that identifies the related 510(k) clearances for that particular product code, recall reports, and medical device reporting (MDR) information for the product code selected.

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Innovation and the Quality Process

by Ken Peterson, MasterControl Inc.

Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future?

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Is SOP Online Training More Compliant?

by Vivian Bringslimark, HPIS Consulting, Inc.

According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

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