ISPE GAMP©5 2nd Edition changes & application: FDA CSA Draft Guidance Initial thoughts
Life Science Series
20 October 2023 10:00 AM EDT
Join Ideagen’s Stephen Ferrell, an ISPE GAMP©5 second edition contributing author as he shares some of the key updates to ISPE's definitive guide to computer system validation and software assurance. Stephen will cover key changes to the guidance in addition to his preliminary thoughts on the US FDA's draft computer software assurance guidance document.
- GAMP©5 has been updated for the first time in 13 years to provide contemporary guidance for the cloud, artificial intelligence/machine learning, and blockchain and critical thinking in the context of IT governance and software assurance.
- A review of newly added appendices and contemporary updates to previous guidance.
- An understanding of the applicability and definitions of computer software assurance period.
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.