Scheduled for Sunday, 13 October, these workshops are crafted to equip industry participants with the tools and knowledge to navigate the fast-evolving landscape of pharmaceutical technology and compliance. The workshop lineup includes:
Dive into the digital future with this workshop, which focuses on the end-to-end integration of technology to enhance operational excellence and quality. Participants will learn how to harness digital tools effectively using the ISPE Good Practice Guides, ensuring their organizations can capture, maintain, and share crucial knowledge to remain competitive.
For those interested in the regulatory aspects of digital technologies, the “Technology in Alignment with EU Guidance and eClinical GPG” workshop is highly recommended. Led by experts such as Geetanjali Abbi from Alkermes; Brandi Stockton from The Triality Group, LLC; Petch Ashida Druar from Syneos Health; and Lorrie Vuolo-Schuessler, a Qualified Instructor with ISPE and a past Chair of GAMP Americas, the workshop will dissect the complexities of implementing digital tools such as AI in support of clinical trials and other key aspects associated with drug development and approval, focusing on the latest EU regulations. The discussion will reference the recently published ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition). With an emphasis on decentralized clinical trials, good clinical laboratory practices, data science and AI-enabled systems, and real-world data/real-world evidence, attendees will walk away with a robust understanding of navigating these innovations within a regulatory framework.
Quality management is a cornerstone of pharmaceutical success, and this workshop will explore the ISPE Advancing Pharmaceutical Quality™ (APQ) program. Experts like Thomas Friedli from the University of St. Gallen; Tami Frederick from Perrigo; will guide professionals through the Advanced Pharmaceutical Quality (APQ) framework designed to assess and elevate quality management practices. Participants will learn strategies to drive continuous improvement and achieve excellence in quality management within their organizations. Attendees can expect to delve into the APQ framework designed to assess and improve quality management practices, driving continuous improvement within their organizations.
Explore innovative strategies for reducing costs in cell therapy production through case studies and practical applications. This workshop focuses on optimizing processes, mitigating contamination risks, and maximizing facility efficiency, providing participants with actionable insights to improve cost management. Ken Rando with COMECER; Evan Lamb with SKAN US, Inc.; Jeffrey Odum from Genesis AEC who is also an ISPE Qualified Instructor; David Raab with Genesis AEC; and Eric Bozenhardt with United Therapeutics will lead this informative session.
These workshops are designed to provide industry professionals with the insights and strategies needed to tackle current challenges and seize future opportunities in pharmaceutical engineering. With a focus on practical application and expert-led discussions, the 2024 ISPE Annual Meeting & Expo workshops are a must-attend for anyone looking to advance their expertise and contribute to the industry's growth.
Leadership is a crucial skill also in the pharmaceutical industry. Led by industry leaders and two regulators from the US Food and Drug Administration (US FDA), this Women in Pharma®-powered workshop is ideal for those in leadership roles seeking to enhance their influence and adaptability. Designed by Guido Kremer-van Der Kamp from Merck Chemicals GmbH and Yolanda McLean, Senior Director, Quality Control from Alnylam Pharmaceuticals, with participation from Jill Hammond, from the US FDA, and Commander June Page, also with the US FDA, this workshop covers crucial skills such as emotional intelligence, trust-building, and fostering team confidence, essential for thriving in dynamic regulatory environments and enhancing audit and compliance processes.
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The significance of these workshops extends beyond their mere content. They represent a unique opportunity for professionals to engage with thought leaders and peers, fostering an environment of collaboration and innovation. The diverse range of topics covered ensures that there is something for everyone, from digital transformation to cost optimization. The networking opportunities are invaluable, allowing attendees to connect with industry pioneers and expand their professional circles. Attendees will benefit from cutting-edge knowledge, enhance their professional skills, and participate in interactive sessions that encourage practical learning and engagement. The ISPE Annual Meeting & Expo serves as a catalyst for professional growth, offering attendees a chance to stay ahead of the curve in pharmaceutical engineering.
Don't miss the chance to be part of these transformative workshops and connect with industry peers and leaders. Register today for the 2024 ISPE Annual Meeting & Expo to accelerate careers and drive innovation in the pharmaceutical industry. ISPE looks forward to welcoming pharmaceutical professionals and regulators to an event filled with learning, collaboration, and inspiration.
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