Concurrent Session: GAMP® 5 - Critical Thinking, Agile Methods, and IT Infrastructure Control|This session will focus on how the GAMP® 5 model is evolving to adapt to the current changes in digitalization.  The topics in this session include: Understanding the flexibility of GAMP® 5, that Agile does demonstrate control and how records or tools can be used in place of documentation. Critical Thinking is a mindset that must be applied when implementing GAMP® 5 to ensure that a risk-based approach to quality and compliance takes account of the multiple layers of assurance that may exist upstream or downstream of the system within the business process it supports. The use of Good IT Practices, electronic IT Service Management Tools and Automation as an effective means of achieving continuous compliance of the IT infrastructure environment including cloud and on premise.

Concurrent Session: CAR-T and the Future|The future of gene therapy to most effectively meet the needs of our global population requires focused agility for development and manufacturing. Speed and flexibility are at the forefront and & innovations like adaptive facilities and ethical supply chains are integral for success. This session represents a collection of case studies focused on how facility design is changing to keep up with this rapidly evolving field. Please join us for a discussion around various design solutions and best practices that can support how to make these facilities work both technically and financially.

Concurrent Session: Innovations in Supply Chain and CGT Operations|Cell and Gene Therapies (CGTs) are a growing field with its own set of challenges. The science of these innovative therapies is incredible, but so are the logistics and costs around supply chain and process efficiency.  The sheer number of systems in these facilities requires a great deal of material that can create material/process/personnel/waste flows that can lead to inefficiency and increase the Cost of Goods (COG).  In addition, supply disruptions during the COVID-19 pandemic have exposed many vulnerabilities across our supply chains for drugs and medical devices.  Implementing an efficient and flexible supply chain, is critical.  In this session, the presenters will use their design, operational and technology experience to lay out some of these challenges specific to CGT and demonstrate how proper design, materials planning and decentralized supply chain management can, increase flexibility, lower the cost of goods and improve the efficiency of getting medicine into the right hands at the right time.

Concurrent Session: Path to a Global Quality Dossier - Part 2|Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide.  A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines.  The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained.  This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry.  ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented.  Part 2 presentations will explore patient centric approach to post approval changes and how structured quality data combined with analytics can facilitate consistent and faster regulator assessment.  Part 2 will also include a panel discussion and Q&A with all of the presenters from both Part 1 & Part 2.

Concurrent Session: Learnings from COVID - Innovations for Parenteral Productivity/Capacity|The COVID pandemic has led to a spotlight focus on parenteral operations capabilities and capacity as the industry responded in an unprecedented manner to the need to innoculate billions of people.  Leveraging and scaling technologies and adapting at speed to the emerging therapeutic and vaccine needs has driven a ‘barrier breaking’ mentality within companies and as illustrated by these three case studies the results were spectacular. The presentations will enable attendees learn about approaches to agile and innovative execution that are hopefully also applicable to other technology platforms.

Concurrent Session: This session discusses two topics in the landscape of modern modeling. In the first, attendees will be exposed to new categories of DoE options and learn the potential advantages of these modern designs compared to classical designs. The second topic focuses on the validation of AI applications. A validation strategy based on an AI maturity model is described, including the benefits of implementation of the maturity concept.

Concurrent Session: Lifecycle Management and Modernization|The focus of this session will be on the implementation of modern computerized systems in the pharmaceutical industry.  The presentations in this session will provide insight on how to approach implementing your own specific computerized system strategies through critical thinking and risk analysis.  After participating in this session you will have a better understanding of how to practically modernize software compliance methods for computerized systems in the future.

Concurrent Session: Pharma and the Environment - How Will We Meet the Needs?|This session will take a good look into how the pharma industry is committing to reducing or eliminating their impact on the environment.  As the industry looks into environmental controls, sustainability programs and reducing the carbon footprint how are companies evaluating existing buildings, new capital project requirements and other options for renewable energy.  These presentations will take a look into options while the case study review will show how the outcomes can be paramount.  Overall environmental programs from design to construction through operation are key for minimizing impact and obtaining some of our LEED and other awards.  Please join us for the next generation of environmental discussions.

Concurrent Session: SCOPE Response To Pandemic Challenges|Welcome to our session titled ‘Response to Pandemic Challenges’! This aptly named session features two presentations – 1. Resilient Manufacturing for Handling Disruptions, and 2. Pandemic-inspired supply chain solutions. Even before the COVID-19 pandemic challenged the life sciences industry, demand in the life sciences construction sector was outpacing supply. But with the pandemic, Project Warp Speed and COVID-19 vaccines fueling new demand, the supply chain is struggling to keep up with demands and supply for key ingredients and finished products. This session will examine some key aspects, including but not restricted to: Designing digital and agile manufacturing process to mitigate the effects of disruption Plan how to make manufacturing more agile Understand how the life sciences industry can adapt to supply chain delays Share lessons learned to strengthen domestic supply chains through improved manufacturing and construction techniques Come join our dynamic presenters – Jeff Peragallo (Director and VP of Operations at Linesight), Brian A. Curran (Sr. VP at MasterControl) and Regina Fullin (VP of Regulatory Affairs and Quality Assurance at Compliance Team).