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The revised ISO 15189 | ISO 15189 compliance
In this webinar, we have explored best practice for when companies are transitioning to the recently revised ISO 15189:2022 standard.
Watch Dr David Ricketts and Stephen Ferrell, experts on the standard, as they 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.
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key takeaways
What you will learn
- Ensuring your lab’s compliance with the new changes.
- The key risk factors in the revised validation and verification process.
- How the revised ISO 15189:2022 has framed risk and opportunity.
About this webinar
Discover Risk, validation & the revised ISO 15189 Program
With a greater emphasis on risk as one of the main changes in the new standard, the webinar also focuses on how ISO 15189:2022 frames risk and opportunity.
Meet our speaker
David Ricketts
Founder, David Ricketts Consultancy LimitedDavid Ricketts has extensive experience in writing standards and leading ISO projects, including the ISO 15189 revision.
Stephen Ferrell
VP IT Governance & Software Assurance, CompliancePath Limited, an Ideagen CompanyRecognised 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.
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