Applying GAMP5 to AI/ML based systems

Applying GAMP5 to AI/ML based systems

After our successful event in April 2023 on AI/ML we get many requests to continue on this subject. We are very happy that Dr. Tom Williams is available for our next Knowledge Café to present a practitioner’s guide to AI/ML systems. The Knowledge Café will include a Q&A, please enter your question(s) during the registration.

The Teams invite will be send about 1 day before the event.Knowledge Cafe

Event Properties

Event Date 22-Feb-2024 12.30
Capacity 50
Registered 50
Individual Price Free
Location Online - Teams



Applying the GAMP 5 life-cycle approach to the Artificial Intelligence / Machine Learning based Systems

by: Tom Williams
A practitioner’s guide to AI/ML systems and how to apply the GAMP-5 methodology throughout their lifecycle to ensure quality, efficacy and reduce risk to patients and of project failure. This is a whistle-stop tour through the complete lifecycle of AI/ML system, from concept through project to operation, identifying the key milestones and decisions that determine quality and success. The theoretical description will be interleaved with real-world case studies to illustrate and aid explanation of the concepts. This talk aims to demonstrate that the potential downsides of AI systems can be overcome by best practice risk-based approach to the development and operation.


Questions & Answers

Open discussion


Tom Williams

Chief Technical Officer of Manchester Imaging Ltd

Dr. Tom Williams has more than 30 years of experience of AI in both academic and commercial sectors, and is a practitioner of cutting-edge computer vision and machine learning algorithms. As the Chief Technical Officer of Manchester Imaging Ltd., he has developed multiple Software as a Medical Device (SaMD) AI products. Manchester Imaging develop their own AI products and undertake contract work with other companies to identify and realize the benefits of AI/ML in a range of healthcare applications such as drug discovery, disease detection diagnosis across diverse clinical domains including skin oncology, musculoskeletal, and osteoporosis. Dr. Williams is a key opinion leader at the forefront of devising best practice in the development of AI/ML solutions in the healthcare sector to maximize patient benefits and minimize risk. He is a GAMP 5 2nd Ed Contributing Author and has been an invited speaker and panellist at multiple ISPE meetings

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