Tech Talk

Keep in touch with the top industry topics.

Data Integrity

Wednesday the 12th March 2014

By: by Maxine Fritz, EVP of NSF Health Sciences Pharma Biotech, George Toscano, Senior Director of Quality Systems, Pharmaceuticals, Biotech and Biologics, and Darren Jones, Consultant, NSF Health Sciences Pharma Biotech

Make sure this hot topic doesn’t burn you … or your suppliers, contract manufacturers or contract laboratories

How confident are you that there are no data integrity issues within your firm, or within the many suppliers, contract laboratories or contract manufacturers you use in the developmen...

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The Qualified Person In The New European Regulation

Tuesday the 3rd December 2013

By: James Pink

This brief article outlines the new EU requirement for a “Qualified Person” (QP) which is contained in the EU Regulation due to replace the current medical devices Directives 93/42/EEC and 90/385/EEC. The new Regulation has been the subject of fierce debate between the various stakeholders throu...

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Preparing for Unannounced Inspections From Notified Bodies for Medical Devices

Friday the 8th November 2013

By: James Pink, VP Europe-Health Sciences Medical Devices at NSF International

Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health Sciences Medical Devices at NSF International, provides a little help to prepare for them.

Background

There are two important documents that are ...

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How to Prepare for the ICH Q3D Elemental Impurities Guideline

Monday the 9th September 2013

By: Janeen Skutnik, Vice President at NSF Health Sciences, Pharma Biotech.

The upcoming implementation of the International Conference on Harmonisation’s ICH Q3D Guideline for Elemental Impurities and the United States Pharmacopeia (USP)’s General Chapters for Elemental Impurities has triggered its fair share of concern and uncertainty. Some of this is due to the unkno...

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How Applying the Principles of HACCP Can Make You a Better Auditor

Wednesday the 29th May 2013

By: Bob Pietrowski

Whenever I carry out an audit, I come away with two nagging questions in my head – “Did I give enough time and attention to those things which are most important?” and “Did I really communicate my concerns effectively to the auditees and are they motivated to make improvements and act on my reco...

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