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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...
Read More“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...
Read MoreJohn 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...
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