News, Views & Updates

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Food Defence

“Food defence is the effort to protect food from acts of intentional adulteration or tampering” (FDA) FDA has a leading role in a number of food defence initiatives to protect food from acts of intentional adulteration or tampering and to assist facilities to prevent, pre...

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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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Food Safety Culture – What is the purpose of and implications for (EU) 2021/382?

The newly published commission regulation (EU) 2021/382 amending regulation 852/2004 requires all food business operators to establish, maintain and provide evidence of an appropriate food safety culture. This legal requirement is a new departure as culture can be quite a subject...

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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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