Gain access to best practices from industry experts on achieving operational excellence in manufacturing and quality control. This track covers a wide array of themes, including insights from ISPE guidance documents, facility design case studies, and the practical applications of digital technology and advanced analytics. Attend sessions dedicated to 503B compounding and explore the human aspects influencing manufacturing and operational excellence, such as leading a culture of collaboration and impactful technical leadership. Whether pharmaceutical professionals are looking to implement continuous manufacturing in facilities or enhancing their current operations, this track offers practical insights and real-world examples from industry pioneers.
The 2024 ISPE Annual Meeting & Expo track focused on regulatory, compliance, and quality provides in-depth analysis of the latest regulatory requirements and best practices for maintaining compliance. From understanding global regulatory harmonization efforts to implementing robust quality systems, these sessions will equip professionals with the knowledge needed to navigate the complexities of regulatory compliance. Don’t miss the expert-led discussions on ICH guidelines and its implications for continuous quality assurance , or "Regulatory Considerations on Complex APIs' Sameness" by Maotang Zhou from the US Food and Drug Administration (US FDA), who will provide insights into the challenges of ensuring the sameness of complex APIs.
In the face of global challenges, the sustainability and supply chain resiliency track focuses on reducing resource consumption and optimizing energy within the manufacturing process. For example, John Magner from Johnson & Johnson will present "Our Journey Towards Low Embodied Carbon Facilities," highlighting strategies to quantify and reduce carbon footprints in pharmaceutical construction projects. Delve into the latest strategies to enhance supply chain resilience, reduce risks, and improve efficiency across the pharmaceutical supply chain. Additionally, explore the regulatory landscape related to drug shortage prevention, top area of concern for the industry, in “Drug Supply Shortage Prevention: Where are we?” with Jessica Hale from Merck & Co Inc. Join ISPE and potentially thousands of attendees to explore how to future-proof supply chain operations as well as ensure the seamless delivery of life-saving medicines.
This track provides crucial insights into navigating regulatory challenges and development hurdles for advanced therapy medicinal products (ATMPs) to streamline commercialization. Learn about advanced, sustainable technologies and facility designs tailored for ATMPs, and explore the importance of industry collaboration and readiness. The sessions highlight how partnerships among regulators, manufacturers, and suppliers can accelerate therapy adoption, reduce costs, and enhance the next generation of treatment delivery. Sessions like "ATMP Regulatory Collaboration and Organizational Readiness" by Jon Halling and Alfred Penfold will examine successful strategies for compliance and facility design.
The 2024 ISPE Annual Meeting & Expo’s digital transformation track will help attendees harness the power of data to drive decision-making, improve processes, and enhance patient outcomes. In the session "Overcoming Challenges of Digital Innovation (AI)" by Eric Staib from Syneos Health and Brandi Stockton with The Triality Group, LLC, attendees will explore the integration of AI in manufacturing, focusing on data governance and agile development. Gain a better understanding of GxP computerized systems and learn how digital transformation can drive efficiency and innovation. Data scientists, pharmaceutical engineers, and professionals across all sectors within the industry can benefit from this track, which offers valuable insights into the transformative power of data.
The 2024 ISPE Annual Meeting & Expo education tracks consist of more than just sessions—they provide opportunities to engage with the brightest minds in the industry, explore new ideas, and elevate your career. With over 50 sessions to choose from, attendees can tailor their experience to their specific interests and professional goals.
Don’t miss out on this chance to gain cutting-edge knowledge and connect with industry leaders. Register today and start planning which top sessions to attend at the 2024 ISPE Annual Meeting & Expo.
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