Life Science Assurance: Cybersecurity & Data Integrity

Stephen Ferrell is the Chief Strategy Officer at Strike Graph, where he brings his expertise in software assurance, IT governance, and cybersecurity, with extensive experience in managing IT compliance for various regulatory standards like GDPR, HIPAA, and ISO 27001. A Penn State graduate, he holds CISA and CRISC certifications.

Over 25 years of progressive experience in the pharmaceutical industry. Practical, results oriented individual, able to work effectively with a wide variety of people. Ability to work on cross-departmental and cross company projects as project lead. Manage multiple tasks while maintaining established deadlines and overall project perspective. Excellent communication and interpersonal skills. Experience in Computer System Validation, Internal Quality Assurance, Data Management, Laboratory Robotics, Drug Discovery, Informatics (Bioinformatics), Project Management, Documentation, Laboratory Testing, cGLP’s, cGMP’s (Sterile Manufacturing), & cGCP’s, and 21 CFR Part 11.

Brandi Stockton is Founder and Managing Partner of The Triality Group, LLC, which provides technology, quality, regulatory, and compliance consulting services for the Life Sciences industry. She has 20+ years’ of GxP experience with a specialization in computer systems quality and data integrity. Brandi is Vice President of ISPE Great Lakes Board of Directors, is a member of the ISPE GAMP Global Steering Committee, serves as Chair of GAMP Americas, and is Co-Chair of the GAMP Global Software Automation (SA) and Artificial Intelligence (AI) Special Interest Group. She is also a member of the ISPE AI Community of Practice Steering Committee. Brandi has delivered presentations at numerous industry conferences, co-authored published industry articles, and contributed to several GAMP® Good Practice Guides, including the GAMP® 5 2nd Edition.

As Practice Director and Engagement Executive, Ryan will be accountable for overseeing the day to day completed by his HITRUST SME team and supporting staff; this includes review and final signoff on the program prior to submission to HITRUST for certification. Ryan’s experience includes conducting multiple ranges of large-scale cyber security and privacy assessments. He oversees our team of HITRUST SME’s that will be utilized within your engagement. Like Brad, Ryan has worked with the majority of 360 Advanced Healthcare HITRUST clients and is in his second 2-year cycle siting on HITRUST’s External Assessor Council.