Category Archives: Life Sciences

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Five New Life Sciences Courses Launched!

Here at SQT Training, we are delighted to announce that we have launched five new training courses! These courses have been developed in response to ongoing customer requests for these specific training topics. Visit our course pages below to see details of the course content. Al...

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How to Create a Risk Management Plan – Medical Device

Risk management standard ISO 14971:2019 has specific requirements for a Risk Management Plan. In order to comply with the standard, it is important that medical device manufacturers address these requirements in their own plans. In this blog, John Lafferty, our Life Sciences Prog...

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What are the top ten CAPA deficiencies?

John Lafferty, our Life Sciences Programme Director has compiled a list of the top ten CAPA deficiencies based on many years of working with Medical Device and Pharmaceutical manufacturing companies. Our CAPA training course will examine and demonstrate how to eliminate these d...

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Harmonisation of Z Annexes for ISO 14971:2019 in Q1 2022

The Z Annexes for ISO 14971:2019 have been published and will be Harmonised in Q1 2022. It has been a long two years since ISO 14971:2019 Medical Devices – Application of Risk Management was published but the European Amendment containing the Z Annexes has finally been publishe...

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Making the best use of the FDA Inspections Pause

Our Life Sciences industry expert Tutor, Gerry Burke, makes some suggestions as to how Medical Device, Pharma and Biopharma manufacturers can make the best use the ongoing pause in FDA Inspections. The FDA has stated that it has ‘no plans to resume foreign inspections for opera...

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