Vanessa Vasadi Figueroa
Vanessa Vasadi Figueroa is a sterility assurance and contamination control leader with more than 20 years of experience supporting pharmaceutical and medical device manufacturers. She advises organizations across the regulatory lifecycle, from process design and microbial risk assessment to inspection readiness and continuous improvement. Her expertise includes aseptic processing, environmental monitoring strategy, and integrated contamination […]
Dr. Raminderpal Singh
Dr Raminderpal Singh is a recognised visionary in the implementation of AI across technology and science-focused industries. He has over 30 years of global experience leading and advising teams, helping early- to mid-stage companies achieve breakthroughs through the effective use of computational modelling. Raminderpal is currently the Global Head of AI and GenAI Practice at […]
Dr. Michael J. Miller
For more than 37 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Microbiology Consultants, LLC. In his current role, Dr. Miller advises multinational companies in the areas of microbiology, quality and regulatory affairs in support of rapid […]
Malcolm Rossi
Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly […]
Accelerating automation and moving towards ‘lights-out’ facilities
Manufacturing sites offer increasing important opportunities for streamlining and optimising process, productivity and quality. This session will look at how robotic technologies can be harnessed for the safe and effective scaling of manufacturing, including:
Boosting manufacturing efficiency and reliability with AI
Moving from buzzword to bold implementations, artificial intelligence (AI) could have applications across the pharma manufacturing value chain to improve areas such as yield analytics and stock level maintenance. This session will look at where, and how, AI can boost to boost pharma manufacturing’s efficiency and reliability, including:
Digital transformation and pharma manufacturing
From digital twins and artificial intelligence (AI) to the Internet of Things (IoT), individual technologies are being steadily integrated into pharma manufacturing processes, but wholesale digital transformations remain elusive. This session will cover the big picture of digital and manufacturing, presenting strategic approaches to digitalisation, including:
Navigating regulatory change in the US and Europe
Amid unpreceded regulatory disruption, and landmark legislative change, biopharma manufacturers are being subjected to an onslaught of new directions with which to contend. This session will focus on some of the key challenges facing biopharma manufacturers as they strive to remain responsive to regulatory changes, including:
Quality control, and reference standards, in the GLP-1 era
The evolution of GLP-1 drugs from successful diabetes treatments to industry-shaping obesity products has brought with it critical quality control and regulatory compliance challenges. This session will discuss how pharma manufacturers can ensure test methods’ analytical accuracy when identifying and controlling impurities, including:
Lightening the nitrosamine load
Regulatory requirements for nitrosamine impurities are evolving, and the long-running issue continues to present pharma manufacturers with significant risk assessment, confirmatory testing and control strategy implications. As companies contend with the management of nitrosamine drug substance-related impurity (NDSRI) formation across a growing number of products, this session will cover:
