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Risk, validation & the revised ISO 15189 – Ensuring a smooth transition
In this webinar, we will be exploring best practice for transitioning to the recently revised ISO 15189:2022 standard. Join Dr David Ricketts and Stephen Ferrell, experts on the standard, as we give you all the tools you will need to ensure your lab’s compliance and deep dive into the changes, refinements, and key risk factors in the revised validation and verification process requirements. With a greater emphasis on risk as one of the main changes in the new standard, the webinar will also focus on how ISO 15189:2022 frames risk and opportunity.
David is the Head of Process Improvement at Health Service Laboratories, part of the wider Sonic Healthcare Group, in central London, and the managing director of his own consultancy firm, in which capacity he is speaking today.
Chairing the UK mirror committee to ISO/TC 212 and as the head of delegation for the UK on the international ISO/TC 212 committee, David has experience in writing standards and was the project lead on ISO 22870, on the drafting team of the new ISO 15189, as well as being involved in many other standards including ISO 22367. The commentaries are designed to explain the changes in the latest version of ISO standards and explain how to use them in a laboratory setting.
Having spoken nationally and internationally on a wide range of subjects including quality and compliance, David is speaking on risk and safety and the latest version of ISO 15189 at the IBMS (Institute of Biomedical Science) conference this year in Birmingham.
Recognised as an expert in regulatory compliance in the Pharmaceutical, Medical Device and Biotech space, Stephen has held executive and senior level management positions with several technology firms in the life sciences. As the co-founder of CompliancePath Ltd, Stephen continued to become VP IT Governance and Software Assurance after CompliancePath’s acquisition by Ideagen.
Stephen has implemented quality management systems across numerous companies at both the corporate and divisional level and has hosted and conducted countless audits across the GxP disciplines, ISO13485 (inclusive of IEC62304/ISO14971), ISO27001, SOC 1 & 2, EHNAC and FEDRAMP.
As a ‘Beachhead advisor’ for the New Zealand Government, Stephen assists NZ health & life science companies who wish to commercialize in the United States. He is a member of the ISPE GAMP Steering committee, formerly chaired the Cloud Special Interest Group and was the project lead for the ISPE GAMP IT Infrastructure Control and Compliance Guide published in August of 2018. He was also a contributing author to GAMP Good Practice Guide: Enabling Innovation and GAMP5 2nd Edition.
Stephen is a trusted advisor to the US FDA, having provided CSV, Cloud and Data Integrity training directly to field consumer safety officers, collaborating with the UK’s MHRA and providers regular trainings in support of the Chinese NMPA.