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Unannounced Audits: Are You Ready?

How to Prepare and What to Ask of Your Suppliers:

In an effort to thwart fraudulent medical manufacturing practices, the European Commission published a Commission Recommendation (2013/473/EU) focusing on the assessment and auditing practices of notified bodies in the field of medical devices.
A particular emphasis in this Recommendation has been placed on unannounced audits. Unannounced audits are additional assessments by notified bodies of manufacturers and/or their critical material suppliers. Auditors commissioned by the notified body will be able to arrive on site without giving the manufacturer prior notice and proceed with inspection. Over 5,000 unannounced audits are expected this year alone and come in addition to the initial surveillance or renewal audits of a three-year certification cycle.

Now is the time to make sure you and your supplier’s quality and supply chain management systems are in place and you have full transparency. Join us for this informational webinar discussing this trending regulatory standard and learn about what you and your suppliers should be doing to proactively prepare.
Recorded Jul 8 2015 35 mins
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Presented by
Eric Reyes, Customer Insight Manager & Brigitte Mangiarotti, Manager Quality Services, EMEA
Presentation preview: Unannounced Audits: Are You Ready?

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The Life Science Business of Merck KGaA, Darmstadt, Germany Webinar Channel features scientific presentations from key specialists in analytical chemistry, biology, chemistry and life sciences on the practical and technical aspects of new developments and innovations, to help advance your research.

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  • Title: Unannounced Audits: Are You Ready?
  • Live at: Jul 8 2015 2:00 pm
  • Presented by: Eric Reyes, Customer Insight Manager & Brigitte Mangiarotti, Manager Quality Services, EMEA
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