The aim is to explore the potential of Digital Transformation and Pharma 4.0™ projects within the Life Science Industry. Enabling technologies alone are not the answer to challenges that our industry has to face, but they are a key element of a wider solution, inclusive of revised business and compliance processes, innovative and sustainable digital solutions and equipment and, as a key enabler, new organization and culture.

New opportunities offered by recent and emerging technologies are completely changing the game and making new scenarios possible, even the ones considered impossible a few years ago. Our goal is to deep dive transformational, but industry proven, ways of extracting benefits from Digital Solutions that combine one or more innovative enabling technologies, like: GxP Cloud, Smart and Wearable Devices, Collaboration Platforms, Big Data and Advanced Analytics, Industrial Internet of Things (IIoT), Artificial Intelligence / Machine Learning (AI/ML), Process Mining, Natural Language Processing, Image Recognition, Advanced Modeling, Advanced Robotics, Augmented Reality (AR), Virtual Reality (VR), Additive Manufacturing, Robotic Process Automation (RPA), but also the ones less mature in our industry like: Biometric identification, Blockchain, Speech and Gesture Recognition, Edge Computing and Quantum Computing.

Each case study to be eligible should clearly share the problem statement, the solution, the benefits (whenever possible quantitative - the dimension of the project, involved Users, timelines), the constraints, and lesson learned. Best will be to have, at least as co-speaker, a representative of the case study owner company.

Inspections and compliance assessment remains a core aspect of pharmaceutical regulation. In recent years there has been increasing focus on internationally harmonized standards across the pharmaceutical development lifecycle. This enhances risk based audit and inspection models and facilitates reliance. As this practice adapts to new industry ways of working, there is increasing expectation for knowledge sharing across GxPs and learning from the inspections of other organizations. Using examples from audits and inspections across the product development lifecycle, this track will:

• Explore how models for organizational maturity and compliance management will impact audit and inspection planning
• See how innovation in treatment modality and technology is driving new audit and regulatory inspection models
• Hear current trends in regulatory findings from GxP inspections and learn from the experience of others
• Understand the available paths to pre-inspection regulatory engagement for innovative approaches, and learning how to prepare for success

TBA

Attendees will learn the ins and outs from the European projects that were recognized with the ISPE Facility of the Year Award (FOYA) in 2023, with presentations and discussions on engineering and project delivery with case studies.

Questions to be answered include:

• What are the right tools in engineering and project management to support efficient investment projects?
• What are the success criteria to deliver investment projects on time with the required quality?

Most failure points are constant basic data development, stakeholder alignment, permitting requirements (when and how to involve regulatory agencies), late commitment for investments, front end loading development, added complexity through new business needs (i.e. sustainability and reliability) and even the business case itself. It takes skill and patience on both the business and the technical site. Case studies and lessons learned will be presented around these topics.

Join our speakers and other subject matter experts to hear about several areas of interest in the computer system validation area, including how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA), how organisations are adapting to a CSA environment, the significant areas of progress and, conversely the remaining challenges.

Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software", many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11, this session will aim to cover the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11.

Updates from the AI/ML (Artificial Intelligence/Machine Learning) CoP will also be delivered with a focus on AI as to how it relates to computer systems.

Interactive sessions will also be included which will provide you with the opportunity to network and engage in discussions with GAMP subject matter experts. Please join us for what should be a very engaging and informative session.