GAMP FORUM – Advance Notice – Event Information for 27th May
Webinar 12:00 to 2:00pm
Introduction
There are always questions around automation / IS system validation – here is an opportunity to get the latest information on ISPE Guidance and also hear more about the topics that everyone is talking about – AI and ML. We also want to use this opportunity to establish a local GAMP COP
Event Outline (2 hours) – (12:00 to 14:00)
- 10 minute Introduction & Meeting
- 20 min – GAMP 5 v2 and GAMP document Overview
- 20 min – Critical Thinking with CSA/Testing
- 20 min AI/ML
- 5 minute Break
- 45 minutes Impact of AI – Panel Discussion & Q&A
We anticipate asking the newly formed GAMP COP to host a face to face GAMP event a couple of months after this event
Presenters:
Eric Staib is Vice President of Corporate Quality at Syneos Health. He has more than 25 years of pharmaceutical industry experience in various GXP areas, including direct experience and leadership for quality systems development/management, software quality engineering, information technology, and computer systems validation/assurance (CSV/CSA). He holds a BS in biology from James Madison University, an MS in quality assurance and regulatory affairs from Temple University, a graduate certificate in project management from Lehigh University, and an MBA in pharmaceutical management from Drexel University. Eric was a previous Chair of the GAMP Americas Steering Committee for ISPE, and currently chairs the GAMP Software Automation and Artificial Intelligence Special Interest Group (SIG), in addition to serving as Secretary of the AI CoP Steering Committee. He has presented at numerous industry conferences in addition to having published and contributed to several concept papers, magazine and journal articles, and good practice guides; including the 2nd edition of GAMP5. Eric has been an ISPE member since 2001 and is a recognized GAMP instructor.
Stephen Ferrell is a renowned expert in software assurance, IT governance, and cybersecurity across multiple industries. Currently, he serves as the Chief Strategy Officer at Strike Graph, a global Compliance Posture Management (CPM) platform provider.
Mr. Ferrell’s extensive industry experience includes managing IT compliance and security processes to ensure adherence to various regulatory statutes and standards, such as GDPR, Global GxP, FDA, MNPA, Health Canada, HIPAA/HITECH, FISMA, FedRAMP, ISO 9001, EHNAC, ISO 27001, SOC 1/2/3, NIST 800:53, HITRUST, and ITAR. A graduate of the Pennsylvania State University he holds certifications as a Certified Information Systems Auditor (CISA) and in Risk and Information Systems Controls (CRISC),
As the co-chair of GAMP Americas and a member of the ISPE GAMP Global Steering Committee, Mr. Ferrell has made significant contributions to the IT Governance and Compliance in the Life Science industry. He was the project lead for the ISPE GAMP IT Infrastructure Control and Compliance Guide Rev2 and a contributing author to ISPE’s GAMP 5 2nd Edition.
Prior to his role at Strike Graph, Mr. Ferrell co-founded CompliancePath Ltd, a Scottish and US compliance services company that supports regulated clients worldwide. Under his leadership, the company was acquired by Ideagen in 2021.
Throughout his career, Mr. Ferrell has held executive, consultative, and senior-level management positions with several technology firms. He represents the Scottish Life Sciences Association in the USA and is a New Zealand Trade & Enterprise Beach Head Advisor. As a trusted expert to the US FDA, Mr. Ferrell has provided training on CSV, Cloud, and Data Integrity directly to the consumer safety officers.
Tanya Sharma is the cofounder of Assurea LLC. Assurea is a quality compliance consulting firm that serves as a Quality and Computer System Validation delivery partner for fast growing biotech and pharmaceutical clients. Assurea provides fractional services for startups and turnkey services for growing companies. Her expertise is in digital transformation and computer system validation for emerging technologies platforms and novel technologies. She is one of contributing authors for the ISPE GAMP 2nd Edition and Co-Leading the Blockchain special interest group. Tanya has also started a campaign called RootingForYou to support underrepresented women and implementation of their innovative ideas.
Michael Martone is Vice President of Quality & Compliance at Apprentice, FS, specializing in cloud infrastructure, AI development and deployment. Experienced in implementing GxP controls in order to de-risk change management while leveraging SaaS agile methodologies. With a diverse background spanning Life Sciences, Medical Devices, Software, Aerospace, and Defense, Michael Martone brings deep expertise in regulatory compliance, AI governance, and technology-driven quality systems. Former Chair of the New Jersey GAMP Community of Practice (COP) and a member of the GAMP Americas Steering Committee.