2023 ISPE Annual Meeting & Expo

This workshop wasn't recorded, and on-demand content only includes the handouts.

The pharmaceutical industry is highly regulated due to its involvement with products that are essential to human health. The Holistic Pharma 4.0 Digital Maturity Assessment is a key step for pharmaceutical companies aiming to implement digital transformation initiatives in the framework of Industry 4.0 or Pharma 4.0. The objective of this workshop is to enable participants to apply and conduct the Holistic Pharma 4.0 Digital Maturity Assessment, evaluate the organization's status and readiness for digital transformation, identify areas for improvement and comprehend the major obstacles they may encounter the path to achieving a higher maturity level. Participants will also learn how to interpret the results of the assessment through a heatmap, which will highlight the organization's strong and weak areas of structural capability. The goal is also to get feedback from the audience of the maturity assessment for content and structure. The workshop is designed for all managers involved in a digital transformation journey like Chief Digital Officers (CDOs), Quality leads, Engineering, IT, Operations and Supply Chain of all kinds of life sciences manufacturing organizations and Service, Equipment and Software providers to assess the organization's maturity in regard to readiness for a digital transformation.

0900 - 0915: Welcome, Announcements, Introductions by Christian Woelbeling
0915 - 0945: Presentation of Pharma 4.0 Maturity Assessment model by Daniele Iacovelli, Vincent Gerber, and Philipp Klaesle
0945 - 1015: Six Pharma 4.0 Industry Surveys - Maturity Lessons Learned by Teresa Minero and Laura Kuger
1015 - 1115: Execution of assessment with participants by Vincent Gerber and Philipp Klaesle
1115 - 1145: Discussing the maturity assessment results by Vincent Gerber and Philipp Klaesle
1145 - 1200: Feedback round for the Pharma 4.0 maturity model approach with all participants

This workshop wasn't recorded, and on-demand content only includes the handouts.

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.

This workshop wasn't recorded, and on-demand content only includes the handouts.

According to Annex 1, Contamination Control Strategy (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.

This workshop wasn't recorded, and on-demand content only includes the handouts.

Designing and Operations of a Flexible Manufacturing Facility Workshop. 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 workshop wasn't recorded, and on-demand content only includes the handouts.

Outline:

ML (Machine Learning) Presentation
ML Hands On Exercise
OEE (Overall Equipment Effectiveness) Presentation
OEE Hands on Exercise

Description:
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. 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.

Note: This is a hands-on workshop; participants are encouraged to bring their own laptops to be able to walk through OEE and ML practice examples led by the workshop instructors.

This workshop wasn't recorded, and on-demand content only includes the handouts.

Join us for an enlightening exploration of leadership in the Pharmaceutical Industry with ISPE's "Leadership 101" program. Designed to provide you with key insights into what it takes to succeed in a leadership role within this sector, this program is an essential asset for your career progression.
Welcome to our informative and engaging workshop, "The Essentials for Leadership Development." This session serves as an introduction to the ISPE's Leadership 101 program. Over a 3-hour span, this workshop promotes self-reflection and fosters both individual and group interactions.
This workshop aims to develop proficiency in three essential aspects of leadership within the pharmaceutical industry:

Leading Yourself: The first part of the workshop is centered on personal leadership. It focuses on aligning your mindset with your actions, while adhering to a set of core values that influence your decisions and interactions with others. A successful leadership journey begins with mastering self-guidance. This workshop offers a valuable opportunity to enhance your leadership skills and better understand the unique dynamics of the pharmaceutical industry. Take the next step in your career journey by expanding your leadership acumen with us.
Leading the Business: The second part of the workshop gives you a basic understanding of how KPIs, revenue, and expenses influence your team's operations. We'll discuss how you can take a more proactive approach to these aspects of your operations and provide practical strategies to help you plan more effectively.
Leading Others: The final part emphasizes the importance of effective communication, particularly in conveying Key Process Indicators (KPIs) and their significance to diverse levels within your team and organization. As technical skills can vary in their application across different companies and teams, we'll explore how to recognize these differences and how to incorporate this understanding into effective communication of team goals and objectives.

Please note that this is an interactive session, so participants are advised to come prepared with a mobile device for full participation in various activities. Attendees should have the free ISPE mobile app downloaded on their device and should already be logged-in to ask questions and maximize engagement.

This workshop wasn't recorded, and on-demand content only includes the handouts.

This conference workshop provides comprehensive insights into the emerging trends, regulatory differences, and technological advancements in the Chinese pharmaceutical and healthcare sector.

1300 – 1310: Welcome by Ping ZHANG
1310 – 1330: Development of ISPE China in recent 3 years by Hongyang LI
1330 – 1400: Comparative Analysis of NMPA/FDA Regulations-Pathway to Entry Chinese Market Successfully by Ping ZHANG
1400 – 1430: Gene and Cell Therapy in China – landscape and regulatory update by Frank GAO
1430 – 1445: Break
1445 – 1515: Manufacturing Excellence on Biologics Products with Single Use Technology and Robust Quality Operations by Sherry GU
1515 – 1545: High performance and Cost-effective Bioprocess Solutions by Peter FU
1545 – 1600: QA/Closing

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 is ONLY 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. Attire is formal, black-tie.

In an ever-increasing VUCA world, supply chains are facing unprecedented challenges and uncertainties - demanding greater resiliency than ever before. But amidst the chaos, there lies an opportunity to build resilience and emerge stronger. In this keynote, Pam Cheng, EVP Global Operations & IT and Chief Sustainability Officer will reflect on a post-pandemic world, taking stock of how the Pharma industry and supply chains navigated COVID-19 - and how well our best laid continuity plans worked.

At AstraZeneca, our supply chain delivers life-saving medicines to patients around the world, and we believe in the strong connection between healthy planet and healthy people. There is a clear synergy between resiliency and sustainability. However, with growing complexity on the horizon, an increase in geopolitical tensions and natural ‘disasters’ growing more frequent and more severe, it’s imperative we understand how climate-conscious decisions we make today, are critical to greater supply chain resilience in the future.

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 an era where the need for groundbreaking treatments to address unmet medical needs has never been more pressing, it is crucial for us in the pharmaceutical engineering community to develop and enable technologies in a timely manner. In this keynote, Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio will address the successful introduction of novel therapies, especially Advanced Therapeutic Medical Products (ATMPs), as a testament to the fruitful partnership between engineers and biological scientists. To accelerate the development of novel therapeutics further, significant opportunities for enhancement remain, particularly in the realms of operational excellence in manufacturing and addressing sustainability challenges related to supply chains and energy consumption. Embracing ongoing disruptive technologies is imperative and inevitable in achieving these goals.

We are thrilled to announce that Robert M. Califf, MD, Commissioner of Food and Drugs at the FDA will be joining ISPE during the 2023 ISPE Annual Meeting & Expo. Commissioner Califf's unique insights and extensive experience in the pharmaceutical and regulatory space promise to shed light on the ongoing challenges and opportunities facing the industry. Don't miss this opportunity to hear firsthand from one of the leading voices in healthcare regulation

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 organizations 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 Second 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.

10:00 – 10:15: GAMP 5 Second Edition – A Year On by Heather Watson
10:15 – 10:35: GAMP 5 Second Edition – Future Guidance by Chris Clark
10:35 – 11:00: GAMP 5 Second Edition - Maximizing Value by Sion Wyn
11:00 – 11:30: Panel Discussion: Computer Software Assurance (CSA) - Opportunities for GAMP 5 Second Edition and 21 CFR Part 11 by Francisco Vicenty, Daniel Walter, Ken Shitamoto, Sion Wyn, Chris Clark and Heather Watson, moderated by Khaled Moussally