Tech Talk

Keep in touch with the top industry topics.

Facility Shutdown Management: Best Industry Practices to Ensure a Smooth Shutdown and a Rapid Startup

Tuesday the 7th October 2014

By: Martin Lush, President, NSF Health Sciences Pharma Biotech

Martin Lush underlines the importance of controlling plant shutdowns so that start-up is on time with minimal disruption to the ongoing supply of products.

“We all have our war stories of shutdowns dragging on for weeks, not days, and it is worrying that after many engineering intervention...

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Do Particulates Matter…? 9 recalls in USA already this year suggest they do!

Tuesday the 10th June 2014

By: John Johnson

The visual appearance of sterile drug products is obviously a key quality attribute for any formulated product, yet the pharma industry still struggles to define, control and set in place effective monitors. Freedom from particulates has been a compendial requirement for three decades so why is ...

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Data Integrity

Wednesday the 12th March 2014

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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A word from NSF Health Sciences

The NSF Health Sciences team make an effort to keep in touch with industry best practice and like to explore the key topics that are hot in the industry. We are always interested in your views so please feel free to tell us what you think about our Tech Talk articles here and in the Journal.

Martin Lush

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