GAMP Forum

GAMP FORUM – Advance Notice – Event Information for 27th May 

Webinar 12:00 to 14:00

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 goal 
• 20 min – GAMP 5 v2 and GAMP document Overview – Stephen/ Brandi 
• 20 min – Critical Thinking with CSA/Testing – Stephen
•  20 min AI/ML – Brandi Stockton
• 5 minute bio 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:

Brandi Stockton is Founder and Managing Partner of The Triality Group, LLC., providing 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. Having held executive and senior leadership positions in IT, Quality Assurance, and Quality Management, she has established and led global programs and teams, championed transformational quality initiatives, and led cross-functional quality system improvements.

Brandi is currently Vice President of ISPE Great Lakes, is a member of the GAMP Global Steering Committee, serves as Chair of the GAMP Americas Steering Committee, and is Co-Chair of the GAMP Global Software Automation and Artificial Intelligence Special Interest Group.

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

Co-Founder, Assurea LLC

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 (pending Bio)