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Det nya medicinteknik/in-vitro diagnostik regelverket har antagits av EU

The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector.

Läs mer i Eu:s pressrelease

Reservera 22 maj 10.00-11.30 eller 7 juni 15.00-16.30 för vårt Webinar där vi presenterar nyheter och viktiga delar i reglerna (på engelska)   www.key2compliance.com/cs5002.php

Från den brittiska tillsynsmyndigheten MHRA:s blogg:
Too much pressure: a behavioural approach to Data Integrity (Part 1)

In this interesting article David Churchward reflects on the international data integrity workshops in China in October 2016. During the workshops, regulators discussed their findings from inspections where breaches in data integrity had been identified. Issues relating to pressure, motivation, and ultimate disconnection between front line employees and their managers were hot topics; and the inspectorate blog provides an opportunity to share some of this experience.

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Anna Lundén talks about Tendencies and developments to be found in observations and warning letters - Video

Anna Lundén, training director and part owner, Key2Compliance AB discuss with Henrik Johanning, CEO, Genau & More.


Den slutliga versionen av "Guidance on CGMP Requirements for Combination Products" har nu publicerats

Denna guide beskriver och förklarar regelverket "The final rule on current good manufacturing requirements for combination products" (21CFR4) som publicerades av FDA 22 januari 2013.

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Current Challenges in Implementing Quality Risk Management

En ny artikel från James Vesper och Keven O’Donnell publicerad i Pharmaceutical Engineering, Nov-Dec 2016.
Ur innehållet::
"The intent of QRM is to make data-driven and scientifically sound decisions proactively, not to justify an action or a decision that has already been taken"
"Formal risk assessments sometimes fail to add value or clarity to a situation because risk assessments often only superficially address root cause analysis, resulting in ineffective risk-control actions"
"Some firms have not yet seen that hazard identification and risk assessment tools can be used together synergistically"

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Relaterad kurs: "Quality Risk Management - Applying the principles and tools", May 8-9, 2017, Copenhagen, Denmark