The pharmaceutical industry is very highly regulated because it deals with products that are essential to human health. The Holistic Pharma 4.0 Digital Maturity assessment is a key step for pharma companies seeking to implement digital transformation initiatives in the context of Industry 4.0 or Pharma 4.0. The goal of this Workshop is for the audience learn to evaluate the organization's readiness for digital transformation and identify opportunities for improvement and to apply and conduct the Holistic Pharma 4.0 digital maturity assessment. After conducting the Holistic Pharma 4.0 Maturity Assessment a heatmap will show the strong and weak structural areas of an organization and to get recommendations in which areas it will help to apply a digital transformational process and to which maturity level.

The Holistic Pharma 4.0 Digital Maturity assessment is a key step for pharma companies seeking to implement digital transformation initiatives in the context of Industry 4.0 or Pharma 4.0.

Key Steps to follow:
1. Conduct the Pharma 4.0 MAturity Assessment: Collect data on your organization's digital capabilities, processes, and infrastructure according to the Holistic Pharma 4.0 Maturity Model, and benchmark them against the chosen framework. You can use surveys, interviews, and site visits to gather information.
2. Analyze the results: Once you have gathered the data, analyze it to identify gaps and opportunities for improvement. Look for areas where the organization can leverage digital technologies to enhance efficiency, reduce costs, and improve customer experience.
3. Develop a roadmap: Based on the results of the assessment, develop a roadmap that outlines the steps needed to improve the organization's digital capabilities. The roadmap should be aligned with the organization's strategic objectives and should prioritize initiatives that deliver the greatest value.
4. Implement and monitor progress: Implement the roadmap and monitor progress to ensure that the organization is achieving its digital transformation goals.

The ability to bring drug products to market in a timely manner is critical to patient health. When manufacturing processes face excessive downtime and/or failures patients risk delay to potentially life-saving therapeutics. The ability to quantify and assign root causes to these process issues can save pharmaceutical companies time and money, while helping drugs reach patients faster. When a plant or unit operation is not performing at its optimal efficiency, it is useful to track downtime and quantify the gap between equipment operation and perfect production. Opportunities to improve production can be understood using the Overall Equipment Effectiveness (OEE) metric.
When out of specification material is produced, organizations can spend precious time and money trying to identify the root cause. Machine learning allows users to compare process data to known periods of good and/or bad production to identify aberrant periods and key contributors.

In this workshop, we will walk through OEE and ML for pharmaceutical processes using Seeq. We will use example process data to:
1.Demonstrate techniques to identify downtime and build out OEE metrics to identify production opportunity
2.Use machine learning to compare process data to a predefined baseline to isolate the key contributor to process upsets.

According to Annex 1, CCS is referred to as a family of documents that unite, evaluate, and record the adequacy of tools used to assure the purity and quality of drug products. The heightened focus on the CCS is centered around not only physical mechanisms to control contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. This workshop will engage attendees in the development of a CCS using a case study and supporting documentation from an existing cGMP facility. Attendees will be exposed to a methodology to develop a CCS that was performed for the actual facility that is used for the case study. Attendees will interact with different procedures and design documents and see how the documents support each other and work together to ensure that the facility operates in a way to prevent contamination of drug products. Attendees will be exposed to the use of Layers of Protection Analysis (LOPA) for the CCS. Lastly, attendees will experience realistic challenges during the creation of the CCS and gain valuable lessons learned from the actual team that executed the same CCS methodology.

The first presentation will focus on the importance of facility programming to develop a thorough conceptual design that sets the project on the right path of an efficient design that meets schedule and cost targets.  The programming approach will walk-through the development of a layout and challenges of defining criteria for a flexible facility.
•Identifying facility requirements and prioritizing needs vs. wants
•Progression of a conceptual layout
•Defining flexibility to provide a basis for the design

The second presentation will be a case study of a CTDMO that will discuss the overall facility and it’s approach to the facility designed for Multi-products, Multi- clients, and muliti-manufacturing and testing areas to provide a facility that provides end to end capabilities for ATMP drug products. The presentation will demonstrate the approach and key drivers for the facility design focused on a flexible suite for multiple products, multiple clients and accommodation of all levels of therapy life cycle including clinical and commercial production considerations.
•Room layout for flexibility in current and future process operations
•Suites designed for ease of change-over and reconfiguration
•Multiple floors with differing room arrangement options
•Understanding challenges of facility retrofit and renovation

This 3-hour workshop consists of 3 plenary presentations and two breakout sessions. ICH Q9 (R1) Topic Leader, Kevin O'Donnell from EMA will summarize the rationale for and changes to the recently issued ICH Q9, Quality Risk Management revision. There will be two industry presentations summarizing ISPE activity to support the ICH Q9 Implementation Working Group with provision of case studies covering the topics of formality, subjectivity, decision-making and product availability. These will be followed by two breakout discussion sessions, each session covering two of the above topics in parallel. A participant could, therefore, attend and contribute to two out of the four breakout topic discussions. The Workshop will conclude with feedback from the breakout groups, a Q&A and closing remarks.

What does it take to be in leadership in the Pharmaceutical Industry?  ISPE's Leadership 101 program answers that question and will position you for leadership.

The Essentials for Leadership Development workshop provides an interactive experience that gives attendees an OVERVIEW of the ISPE Leadership 101 program. In this 3-hour workshop, attendees will have the opportunity to self-reflect and interact 1-on-1 and as a group. 

This hands-on experience focuses on 3 essentials for leadership in the pharmaceutical industry.
1. Leading Yourself: You will be a good leader to others when you first lead yourself. Leading yourself is about developing the mindset to match your actions while possessing a set of core values that drive decision making and interaction with others.
2. Leading Others: How do you effectively communicate Key Process Indicators (KPIs) and the why behind them to various levels within your team and organization? Most people have the same technical skills, but they manifest differently across companies, e.g., accountability might be something else to an engineering company than it would be to a pharmaceutical manufacturing entity. In a similar way, team members are different and may have varying expectations and perceptions about the company's KPI attributes. The second section of the workshop will focus on the ‘how to’ recognize these differences, navigate them, and taking them into consideration while communicating effectively the intended goals to your team. 
 3. Leading the Business: In this final section of the workshop, ISPE dives into gaining a basic understanding of KPIs, revenue and expenses, how they affect you and your team, and what can you do more effectively as a leader to address them while planning your operations.

Check-in, un-wind and relax at the ISPE Sunday Social! Conveniently located on-property, come join us for cocktails, hors d'oeuvres, prizes and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2023 ISPE Annual Meeting & Expo off right!

Join ISPE to celebrate the 2023 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2023 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner. Livestream access ONLY is included in the In-Person All Access Pass and the Virtual All-Access Pass. To attend this event in person, attendees MUST register separately and pay.

Join us for ISPE 14th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & EXPO. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent.

Additional registration and a donation fee of $25 is required to participate.

Scientific innovation is moving faster than ever before. In this environment, top scientific leaders and pharma organizations are driven by the needs of the researchers working across a myriad of scientific platforms, therapeutic areas and methods. Moving beyond the historical imperatives of delivering cost-efficient assets on time, engineering and operations teams must partner with CSOs and other scientific leaders to add exponential value to research settings. Gilead’s Foster City campus is recognized as one of the most sustainable biotech campuses in the world, as evidenced by its use of renewable energy, large-scale solar installations and eco-friendly infrastructure. As Gilead maps out its next decade, including plans for a new Research Center in Foster City, hear from Gilead EVP of Research Flavius Martin, M.D. about the strong partnership between Research and Corporate Operations as the company expands Gilead’s Research footprint to ensure a distinct home that is socially responsible for the company’s community of scientists. The new Research Center will build on Gilead’s history of success in this space, redefine sustainability standards for research buildings and allow the company to attract and retain top scientific talent.

In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organisations are adapting to a CSA environment, the significant areas of progress and, conversely the remaining challenges and understanding how a Maturity model approach may provide a framework to enable innovation and plan future progress.
Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software" on 13th September 2022, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11.  The session will focus on the implications and opportunities of CSA draft guidance and GAMP 5 2nd Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including leading industry experts along with representatives from the FDA.
Please join us for what should be a very engaging and informative session.

In order to address environmental sustainability in the pharmaceutical industry, a holistic approach is needed to address environmental footprint from both operations and products. 
In this interactive session, seven sustainability experts and senior leaders from Roche/Genentech, GSK, and Takeda will share how they have advanced tools to identify opportunities to minimize their environmental footprint, developed operations and product sustainability roadmaps, and have implemented innovative technologies to decarbonize their operations.

As the world attempts to emerge from the pandemic and return to activity reminiscent of pre-pandemic times, there are still uncertainties remaining related to supply chain stability.  Many valuable lessons can be learned from the pandemic and applied to planning for the possibility of another pandemic, or even a tripledemic.  Some global Health Authorities have been active in developing guidance and recommendations to mitigate disruption in the supply chain and secure patient access to critical medicines based on these recent learnings in an effort to improve planning and preventative measures.  Additionally, some governments have imposed legislative measures to encouraging onshoring as a protective measure to insulate domestic supply chains from disruption.  In parallel, to appreciate and align with regulatory efforts to address shortages and supply chain instability, the ISPE Drug Shortages Initiative team has developed expanded guidance on the quality, technical, and regulatory aspects of drug shortage prevention. 
Regulators and experts will present experiences related to securing supply chain, mitigating drug shortages, and efforts to proactively be prepared for the possibility of a future pandemic.

As a result of this session participants will gain:
- Insights from experiences endured during the SARS-CoV-2 pandemic and potentially longer-lasting impacts on the global supply chain, from both regulatory and industry perspectives.
- Overviews of regulatory and industry initiatives which aim to achieve further transparency across the supply chain.
- An understanding of HA perspectives related to regulatory expectations to mitigate drug shortages and supply chain strain (e.g., FDA, EU)
- Opportunities to interact with global regulators (including FDA and European Commission) and industry in a Q&A session and informally at the conference.

To successfully introduce a new therapy to the market, it's crucial to not only focus on the therapy's development, but also on the construction and design of the manufacturing facilities. Our upcoming session will feature speakers who will delve into their own experiences with case studies, providing valuable insights on the entire process of therapy development, from its initial stages to the later phases of facility design and construction. Join us to gain a comprehensive understanding of how to bring a successful therapy to market.

Breakthrough innovations in medicinal based therapies as well as technological device developments have led to the rapid rise in the use of combination products. Risk management  is important as it underpins the success of development, manufacturing, post market surveillance,  and lifecycle management of advanced therapies. Alignment with regulators for efficient regulatory pathways is critical for predictable outcomes.

- Integration of Medicinal and Medical Device Quality Risk Management approaches for successful combination product development and lifecycle management.
- Review insights and best practices for combination products in the EU, discussing both clinical trial applications and Notified Body experience.
- Explore evolving innovations in the combination product space.
- Discussion on the evolving FDA regulatory landscape supporting innovative new combination products.

The Membership Meeting and Awards Lunch is open to all In-Person All Access Attendees. Meet the ISPE leadership and colleagues while learning about significant achievements made by the industry in the past year. Be among the first group to recognize the Overall Winner of the 2023 Facility of the Year Awards (FOYA), and celebrate with your peers as several ISPE International Honor Awards are presented.

The holistic digital transformational approach is the mission of the ISPE CoP Pharma 4.0. The ISPE Baseline Guide Pharma 4.0 created by the CoP Pharma 4.0 is educating on the basic principles of this transformational journey! One of the key prerequisites for a digital transformation is the vertical and horizontal integration. From the beginning the concept of the integration is based on a holistic  “Plug & Produce” concept to build an environment which is based on an interoperable architecture to turn data into knowledge for accurate data based decision making. Getting out of the Lighthouse trap and building interoperable “Manufacturing X” environments!

This session will be focused on the different types of facility designs and installed critical systems that support/enable manufacturing excellence and stability.  First, the audience will learn about Restricted Access Barrier Systems (RABS) that are utilized regularly in the manufacturing clean rooms.  However, not all facilities are designed the same and therefore require unique evaluations before new RABS systems are installed on-site.  A case study analysis will demonstrate how the facility and the manufacturing process before RABS installation are a critical first step to ensure sterility assurance.  Second, the audience will learn about the time-to-market deployment through the use of hybrid modular delivery method.  The case study discussion surrounding the hybrid modular project (“box-in-box”) will demonstrate savings and reduction of site congestion at the site as well as how the design and manufacturing processes impact the environmental impact of the facility as it is built and will be operated.

In this session, attendees will gain insights into the key elements of building a resilient supply chain for cell and gene therapy (CGT) products and it will highlight the challenges that arise in the CGT supply chain and explore strategies to mitigate the risks associated with supply chain disruptions. The session will also delve into the importance of transformational change to maintain product continuity. Attendees will learn how organizations can evolve their supply chain strategy to adapt to the changing market dynamics, emerging technologies, and patient needs. The presentation will showcase real-life examples of companies that have successfully implemented transformational change in their supply chain and the benefits they have achieved. Following that will be a discussion on using connected techonology to drive patient safety. By the end of the session, attendees will gain a deeper understanding of the critical role of a resilient and adaptable supply chain in the CGT industry. They will be equipped with practical insights and tools to build and maintain a sustainable supply chain that can withstand future challenges and disruptions will driving patient safety.

We are living in a time where both industries and regulatory bodies are actively advocating for the integration of advanced technologies more than ever before. Join us in this session as we showcase various examples of these technologies that are readily available to help you reduce costs, improve efficiency, and enhance overall quality. Don't miss out on this opportunity to discover cutting-edge solutions that can take your business to the next level.

The session will discuss the current challenges of static and unstructured PDF-based CMC regulatory submissions for drug applications and the modernization efforts of utilizing structured data for regulatory CMC submissions. The session will address actionable steps companies can take to enable digital transformation to streamline and improve the current process of preparing regulatory CMC submissions. Specifically, the session will provide insights on how industry can incorporate advanced technologies to prepare for emerging global regulatory requirements that will change the CMC regulatory submission and review paradigm. Ultimately, companies will need to modify their internal processes to ensure compliance with new regulatory requirements, but there is less clarity across industry on the roadmap for implementation and how to best navigate a stepwise approach towards modernization. The session will also include a Regulator’s perspective to the challenges of PDF-based submissions and the need of digitization, digitalization and automation to readily capture information and effectively utilize modern knowledge management tools. Recently, FDA’s Office of Digital Transformation (ODT) has rolled out a series of action plans for technology and data modernization. The session will give an overview of FDA’s digital transformation history including some CMC-specific initiatives such as the Knowledge-Aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) initiatives to modernize the CMC submission and review process. Together, industry and regulators can leverage technology to collaboratively build towards a future vision of enhanced efficiency, reduced filing timelines, and improved speed  to market for critical therapeutics.

The first part of the Process Analytical Technology session discusses best practices in the design, implementation, and operation of PAT for actual GMP operations. The design and implementation drive the digital transformation. This includes the IT infrastructure requirements to facilitate the data management under GMP standards, the application of 'classical' PAT based on spectroscopic equipment through to soft sensors i.e., data-driven analytics, and process insights revealed by PAT back to the control strategy as a holistic instrument.
The second part of the session is a case study from Takeda's Neuchatel site, tying the strategic vision of digitalization in manufacturing to the real-time benefits of PAT. The Digital Twin Model allows monitoring, investigation and prediction of critical quality attributes (outputs) by varying the process parameters (inputs). Predictive modeling is a key attribute to ensure operational excellence and a robust manufacturing process. This promises to be a great session showing how far PAT techniques and technologies have moved pharmaceutical manufacturing from feedback, reactive approaches to predictive modelling for maximum efficiency and yield.

This session will highlight the importance of commissioning and qualification throughout the biopharmaceutical facility with a focus on manufacturing operations.  The first speaker will provide an overview on of the current state of the industry, including adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices and key performance indicators.  Second, the audience will learn about the importance of harmonized decision making framework and risk-based evaluation of the need for pre-PV (process validation) through demonstration batch decision flow charts, manufactured batch assessment tools, and case study application.  To conclude this session, the last presentation of the session will discusses relevant topics necessary to develop a comprehensive assessment to characterize cleaning program practices, typical observations from assessments, and sustainability opportunities identified in reduced water usage, optimized chemistries, cleaning cycle duration reduction, potential energy reductions, and developmental studies to support identified solutions.

This session will focus on the integration of sustainable development practices in different aspects of business operations. The first segment, will explore the importance of having a comprehensive sustainability strategy and governance structure in place. Attendees will learn about best practices for setting sustainability goals, measuring progress, and integrating sustainability into the company's overall business strategy. The second segment will showcase the role of technology in driving sustainable development. Attendees will gain insights into the latest trends and innovations in sustainable technology, including renewable energy, green buildings, and sustainable transportation. The presentation will also examine the challenges and opportunities of adopting sustainable technology in business operations. In the third segment, attendees will learn about the importance of product traceability in achieving accurate carbon accounting. The presentation will explore the tools and technologies available for tracking the carbon footprint of products throughout the supply chain. Attendees will gain insights into the benefits of trusted carbon accounting, including improved sustainability reporting and increased stakeholder trust. Over the three presentations, attendees will gain a comprehensive understanding of the critical role of sustainability in modern business operations. They will learn how to integrate sustainable development practices into their business strategy, leverage technology to drive sustainability, and use product traceability to achieve accurate carbon accounting. The session will equip attendees with practical insights and tools to drive sustainable growth and create value for all stakeholders.

It's remarkable how rapidly the field of ATMP development is advancing, with more and more organizations entering this space. In this session, we'll take a closer look at how a conventional biologics manufacturing facility was transformed into a modern, multi-modal facility for ATMP products. Although ATMP products, processes, and facilities have unique characteristics, they are still built on fundamental pillars that we will explore during this session. Join us to gain insights into the latest advancements in the field of ATMPs and how they can be implemented in your own manufacturing facility.

Decisions to pursue and implement pharmaceutical innovations are frequently based on receptivity from global regulatory authorities.  Lack of regulatory convergence can hinder innovation and continual improvement and increase the risk of drug shortages. In recent years, several opportunities have emerged to address some of the regulatory challenges that have been a barrier to manufacturing innovation, including:
- Improvements in risk-based regulatory assessments of applications
- Increased opportunities for direct engagement with regulatory authorities to align on application expectations and standards for new technologies
- Expanded mechanisms for collaborative regulatory review/assessment of applications between regulatory authorities
- Application of relevant learnings from the response to the COVID-19 pandemic toward increased adoption of mutual reliance/mutual recognition between regulatory authorities
- New technologies to improve product reliability, local access, and sustainability

The culmination of circumstances has led several regulator-only organizations to initiate forward-looking programs toward harmonization of product quality reviews and inspections. This session will describe the existing hurdles to be reconciled to improve global regulatory harmonization for innovative technologies and the programs established to build trust and alignment between regulators. The content from presentations from key regulatory authorities and industry leaders will serve as the basis of an integrated panel discussion.

ISPE is proud to host the ISPE Career Center for all levels of the industry from emerging leaders to the most senior executives.  The Career Center booth will feature career-related speakers in a TED talk style format, a headshot photo booth, a career information center, career conversations, on-site interview stations, and a career swag bag raffle.

The Allure of the Ally, Power & Led by Women in Pharma  Let’s travel back in time for a swanky night with some of the most impressive broads and fellas in the industry. The Women in Pharma and Emerging Leaders Monday Night Event - Allure of the Ally - is open to all conference attendees, but capacity is limited to keep the sent off. Only those with a secret password will be allowed into the speakeasy, so reserve your spot today, old sport, to enjoy a night of music, drinks and networking with the best in the biz. Conveniently located on-property at the 1923 Prohibition Bar.

Kick-off your Tuesday morning with an extra dose of power and confidence this Annual Meeting with a ISPE Self-Defense Class, Power and Led by Women in Pharma. Join us on Tuesday, 17 October, at 7 am for a class consisting of traditional boxing methods and combinations to help you defend yourself with confidence. This instructor-led class will provide you with guidance and feedback on forms to ensure a safe and enjoyable experience.

ISPE is proud to host the ISPE Career Center for all levels of the industry from emerging leaders to the most senior executives.  The Career Center booth will feature career-related speakers in a TED talk style format, a headshot photo booth, a career information center, career conversations, on-site interview stations, and a career swag bag raffle.

In this session, the speakers will focus on the equipment selection strategy for continuous manufacturing followed by the importance of API drug attributes and chemistry, manufacturing, and controls (CMC) for accelerated development timelines. The first presentation will discuss the decision-making process and implementation strategies to demonstrate the equipment selection for customized processes in pharmaceutical continuous manufacturing (PCM). The speakers will highlight the critical elements in a holistic PCM equipment design including system interfaces such as mechanical, process, automation, and controls. This will be followed by the second presentation which will discuss a novel approach to address challenges faced during accelerated drug product development. The speakers will explore the process to accommodate API attribute variability and understand the safe operating space for a given product in drug product and drug substance development. They provide a strategy to ensure drug product process selection includes inherent robustness and minimizes the likelihood of any delays due to unforeseen material attribute changes. The last presentation of the session focuses on the criticality of chemistry, manufacturing, and controls (CMC) timelines for the approval and launch of new medicines. The presentation will explore different levers that have been applied or can be applied during development to ensure the timely availability of vaccines and therapies to patients.

Artificial Intelligence (AI) and Machine Learning (ML) are changing the manner in which we manufacture product, analyze data, and improve processes. It is through this digital innovation that we are better able to reduce cost, gain efficiencies, and do so in an ever more compliant manner than ever before. However, such optimizations must be done with an increased focus on data, process controls, and risk-based decision making. Explore two such examples related to batch record data and product development, while discussing one of the newest appendices in GAMP5 2nd Edition.

The COVID-19 pandemic highlighted the importance of supply chain resiliency, but pharmacists have known for years that drug shortages are a crisis. The supply of older medications has been repeatedly interrupted, causing urgent patient care challenges and increasing costs. Over 300 ongoing medication shortages are considered "normal." Vizient has implemented strategies to encourage investment and collaborative efforts to target contributing factors. In this session, we'll discuss the impact of our efforts and how we can partner with suppliers for enduring resiliency.

As with other medicinal products, the success rate of ATMP products reaching commercialization is often lower than desired, if not worse. One critical factor for improving success is having a deep understanding of product critical quality attributes (CQAs) and critical process parameters (CPPs). Join us in this session as we take a deep dive into the discovery and development of advanced therapy medicinal products (ATMPs), sharing experiences and insights to improve the success rate of ATMP product commercialization. We'll also delve into the specific topic of lifecycle management and comparability of AAV gene therapy, using real-world examples to illustrate best practices. Don't miss out on this valuable opportunity to enhance your understanding of ATMPs and their commercialization potential.

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry expert representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself to provide a range of sustainable and practical quality management improvement strategies.

This ISPE Advancing Pharmaceutical Quality Program is a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. It provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System.

Further, FDA will share learnings from FDA QMM Pilot studies and risk management model studies in partnership with St. Gallen University.

ISPE enables industry to proactively demonstrate the value of quality management maturity which benefits regulators, industry, and patients. The ISPE APQ program is a voluntary, industry led program for QMM whereby industry can assess, aspire, act, and advance their level of quality management maturity and share it independently with their patients, consumers, customers, and health authorities globally, based upon international ICH Q10 standards. The APQ QMM program entails quality system assessment, performance measures, improvement tools for advancement, and case studies for robust application.

Training for the ISPE APQ program will begin in 2023 where our expert team will share practical examples and case studies of the five guides in action.

The Digital Journey session will focus on maturity and digital transformation case studies in the life sciences industry. Three different presentations will focus on the challenges and opportunities across the whole product lifecycle of integrating technology, data, culture, and processes to drive innovation, sustainability, and speed to market. The session will explore approaches to developing a holistic approach to digitalization, driving cultural change and organizational development, and designing sustainable facilities for accelerated launch of new molecules. The overall theme emphasizes the need for a strategic approach and collaborative mindset to navigate the rapidly changing landscape of the life sciences industry. Attending this session will provide attendees with some practical strategies, approaches and case studies on how the industry is navigating the digital transformation journey.

- Vision, Ambition, Reality of AZ’s Digitalization Journey provides a framework for digitalization and explains how a holistic approach can help organizations drive sustainability in a fast-changing Facilities and Engineering (F&E) environment. It covers topics such as breaking down silos, using technology to increase innovation, developing an integrated information system, and talent development for digitalization to meet the company's sustainability vision and goals. There will also be a demonstration of the unique integrated solution and framework -  "Facilities Intelligence Dashboard" with the audience.
- Cultural Change in during digital transformation emphasizes the need for cultural change and holistic organizational development during digital transformation, highlighting the fundamental changes in skills, behaviours, leadership, and organizational setup. It also provides examples of how roles in quality and operations will shift from now toward a data-driven environment.
- Digital Maturity - Designing Sustainable Facilities for Accelerated Launch discusses the responsibility of the industry to launch new molecules faster while ensuring sustainable manufacturing practices. It presents an approach to designing sustainable facilities using IT and OT integration to create a river of data that drives value for the business with accelerated launch and sustainability.

This session will explore how Pfizer will achieve their NetZero goals for OSD by 2040 and AstraZeneca’s 'Ambition Zero Carbon' strategy to eliminate emissions by 2025 and be carbon negative across the entire value chain by 2030. The speakers will discuss the current issues and challenges, including the impact of regulatory compliance and quality control on sustainable design practices. They will also delve into the pathways towards achieving NetZero, the impacts of introducing new products, and the constraints on existing facility systems infrastructure operations and monitoring. Additionally, our expert speakers will share their experiences, learnings, and best practices for achieving NetZero in pharmaceutical manufacturing.

This session will explore the challenges and opportunities of introducing new products into emerging markets, with a specific focus on China. The first segment will examine the regulatory and market dynamics that companies must navigate to successfully launch products in these regions. Attendees will learn about the unique cultural, legal, and operational considerations that come into play when entering emerging markets. The second segment will explore the critical link between supply chain security and product quality. Attendees will gain insights into the risks and vulnerabilities that exist in supply chains and the strategies that companies can implement to mitigate those risks. The presentation will also delve into the role of technology in enhancing supply chain security and quality. By participating in this session, attendees will gain a comprehensive understanding of the key considerations and strategies for introducing new products into emerging markets. They will also learn about the critical link between supply chain security and product quality and the benefits of using connected labs for quality assurance. The session will equip attendees with practical insights and tools to drive successful product launches and enhance patient safety in emerging markets.

To wrap up the ATMP and Advanced Technologies Track, what could be more fitting than a discussion on the latest advancements in ATMPs? Since the first CAR-T therapy was approved in 2017, the industry, regulators, and even the general public's understanding of ATMPs has grown significantly. With the need for multi-modal facilities and the development of next-generation manufacturing processes and equipment, we face new challenges as well as exciting opportunities. Join us in this session to gain insights into current trends in facility design, process equipment, and emerging platform technologies. Discover how the latest advancements in ATMPs can help you take your business to the next level.

ICH delivers guidance on science- and risk-based strategies and is an enabler of greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. This session will explore recent updates on ICH Quality Topics including ICH Q12, Q14 and M4Q.

- The ICH Q12 Lifecycle Management guideline was fully endorsed in 2019 and provides a framework for managing post-approval changes. Global adoption and implementation of ICH Q12 continues to present challenges both for industry and regulators. One tool that has shown significant benefits for industry and regulators is the Post Approval Change Management Protocol (PACMPs).  Attendees will learn about the worldwide status of the implementation ICH Q12, with a particular focus on the benefits and challenges of putting into practice PACMPs and established conditions.
- The draft version of ICH Q14, the Analytical Procedure Development guideline, was released for public consultation in March 2022.  Attendees will learn by example how statistical methods can be leveraged to most efficiently and effectively meet several fundamental aspects of analytical procedure lifecycle management described in this guideline.   By applying these methods, scientists can develop more robust analytical methods, identify sources of variability, assure ongoing analytical quality, quickly identify changes in the analytical process, and reduce time for root cause investigations.
- Introduction of the Quality - M4Q(R1) guideline on the Common Technical Document (CTD) in 2002 harmonized the format of quality information for registration of pharmaceuticals. M4Q(R1) is currently under revision to further improve registration and lifecycle management efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals. Attendees will learn about the revisions to this important guideline from one of the PhRMA Experts on the ICH Working Group.

Included in your In-Person All Access Pass! For all other registrants, the add-on fee for the Tuesday Night Celebration is $225.

Key ICH guidelines harmonizing advanced manufacturing approaches such as ICH Q12 and ICH Q13, along with greater international collaboration and other trends supporting more efficient access to medicines for patients, will continue to evolve.  The COVID-19 pandemic allowed regulatory authorities to test some innovative tools while also demonstrating a great need for enhanced global collaboration among regulators.  Challenges across the supply chain, leading to shortages, and other pressures such as the need for increased access to personalized medicines made at the point of care, require increased agilities and innovation in manufacturing.  Other trends with increased focus on underserved populations to support greater inclusion of diverse patient populations during product development and in the post-market add to the complexity of the life-cycle management of products.  Improved efficiencies in product development, clinical trials, manufacturing, and post-market surveillance, including leveraging data systems, AI, and real world evidence for product management, will be required to launch global product development and regulation to the next level.

ISPE is proud to host the ISPE Career Center for all levels of the industry from emerging leaders to the most senior executives.  The Career Center booth will feature career-related speakers in a TED talk style format, a headshot photo booth, a career information center, career conversations, on-site interview stations, and a career swag bag raffle.

Let's join together to celebrate the knowledge shared, connections built, and memories made as we wrap-up ISPE's largest event of the year! Enjoy food and beverages as we say farewell to the attendees, exhibitors and staff who participated in the 2023 ISPE Annual Meeting & Expo. We hope to see you next year.