As data integrity issues increasingly find their way into FDA Warning Letters and Form 483s, regulators are demanding companies determine the root cause of these problems by conducting in-depth, objective employee interviews.

This typically appears in FDA Inspectional Observations with the statement below.

“Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.”

In many cases, regulators expect the scope of these investigations to encompass laboratory and production areas in order to fully explain data irregularities and the causes for them, wherever they originated.

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In today's rapidly-changing marketplace, drug and device companies of all sizes are realizing that a product’s time to market––and resilience once there––depends in large part on developing and executing effective regulatory and quality assurance strategies.

Investors are increasingly expecting streamlined, effective production processes that minimize rework, making quality absolutely essential. This, in addition to the rise in outsourced manufacturing forces manufacturers to comply with complex set of regulations––again underscoring the need for quality across the board.

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The video below is a sample taken from our webinar, The Complete Guide to Root Cause Analysis & CAPA, available free and on-demand here.

The FDA Group's Larry Stevens discusses strategies for determining when Corrective and Preventative Action (CAPA) is appropriate. See transcript below.

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The European Commission has released the first guidance for the upcoming Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulations (IVDR).

Both the EU MDR and IVDR replace the existing Directives, however, the new rules will only apply after a transitional period. For MDR, this period is three years after entry into force (spring 2020). For the IVDR, this period is five years after entry into force (spring 2022).

More recently in March of 2018, a document regarding the requirements for a future EU medical device nomenclature was endorsed at the meeting of the European Medical Devices Coordination Group (MDCG). Access the full document here.

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Most warning letters are issued by the FDA for one of two reasons. Either the company's response to a preceding form 483 was deemed inadequate, or the observations made during the inspection were serious enough to warrant a supporting warning letter.

For the company on the receiving end of a warning letter, determining the proper corrective actions to take typically starts by dissecting the details of the issues cited. Depending on the contents of a particular warning letter, this analysis can be challenging. To help you orient your review, we've highlighted five questions that can help you understand the which corrective actions you will need to take.

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