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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...
Read MoreThe 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...
Read MoreThe 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...
Read MoreOur 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...
Read MoreWith the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, it is a challenge for the industry to obtain suitably qualified software validation engineers to fulfil its requir...
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2024