Discover, Delve, and Develop: Expert Workshops at the 2023 ISPE Annual Meeting & Expo

Digital Transformation (DT):

The ISPE Pharma 4.0™ Community of Practice (CoP) has been instrumental in the development and issuance of guidance on the use and implementation of computerized systems in the life sciences industry. The Pharma 4.0™ Steering Committee is proud to present Holistic Digital Pharma 4.0 Maturity Assessment. This workshop will provide participants with a comprehensive evaluation process and supporting assessment model for companies to evaluate their current status related to DT and identify areas of improvement and obstacles they may encounter on their way to mature their digital infrastructure. The workshop will feature relevant industry surveys from existing companies and the opportunity to execute an actual assessment facilitated by the workshop speakers. The results of the assessment will be discussed in detail with the participants and feedback will be reviewed. Chief Digital Officers, Chief Technology Officers, and Quality, Engineering, Operations, and Manufacturing Leads are all highly encouraged to attend this workshop.

Quality Risk Management (QRM):

The Program Committee is excited to see industry leaders and featured regulator Kevin O’Donnell, PhD, Market Compliance Manager from EMA discern the changes that were seen in the recent revision to ICH Q9. The QRM principles outlined in ICH Q9 are intricate and vital for the advancements of drug development and therapies seen today. This workshop; ICH Q9(R1) and Quality Risk Management, will feature a detailed summary of ISPE’s ICH Q9 Special Interest Group and their activities. Various case studies will be presented around formality, subjectivity, decision-making, and product availability. The workshop will then feature parallel breakout discussion sessions where participants can actively engage in a collaborative atmosphere and gain new perspectives on the topics mentioned above. Lastly, the workshop will summarize the discussions from all of the breakout sessions and foster feedback leaving participants with new knowledge on the revised ICH Q9 principles.

Contamination Control Strategy:

With the implementation of the revised Annex 1 slated for 25 August, 2023, concerns around compliance surrounding Annex 1 are growing and will be at the forefront of the 2023 ISPE Annual Meeting & Expo. At the core of the updated Annex 1 is the heightened focus on the CCS. The workshop Development of a Contamination Control Strategy will feature speakers from Genesis AEC and Kite Pharma, Inc. to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. Participants will learn about the revisions of Annex 1 and hear about the changes from a Quality Leadership position. After that, participants will be assigned breakout groups where the groups will perform a CCS based on an actual cGMP facility. In a collaborative work environment, they will evaluate facility documentation and draw conclusions to be shared with the workshop team and other participants. The workshop will cultivate realistic challenges for the participants that occur in the execution of a CCS. This hands-on workshop is a must for any Quality Assurance Managers, Quality Control Managers, Manufacturing and Operations Managers, and Validation Specialists attending the conference.

Facility Design:

At the forefront of innovative therapies are flexible multi-product facilities that can accommodate all scales of production and support for ATMPs. The workshop Designing and Operations of a Flexible Manufacturing Facility is presented by speakers from Precis Engineering and Center for Breakthrough Medicines. The workshop will feature a presentation from the perspective of an AEC firm on best practices for flexible facility programming to define facility requirements, develop conceptual layouts, and evaluate areas of opportunity to implement flexibility while maintaining patient and operator safety. The second presentation will present a real-life case study of a CTDMO facility featuring multiple products and multiple different manufacturing and support areas. The presentation will feature implementation of the ideals outlined in the first presentation and the key drivers for the chosen facility design. This workshop is a great fit for Process Architects, Process Engineers, Facility Planners, and Engineering and Facilities Managers.

Machine Learning (ML) and Artificial Intelligence (AI):

The Program Committee is proud to present OEE and ML for Process Optimization Using Seeq. Seeq has emerged as a pioneering force in the realm of ML and AI and is redefining the landscape of process optimization to the benefit of the life sciences industry. This workshop facilitated by Analytics Engineers from Seeq will allow participants to explore the functions of Overall Equipment Effectiveness (OEE) metrics and process data and how ML can enhance a company’s ability to determine root causes for reduced OEE. The workshop will feature live analysis of sample process data and give participants the opportunity to experience the power of ML and AI for themselves, possibly even for the first time! This will be an interactive workshop and participants are encouraged to bring their own laptops to perform the analysis with the help of the workshop speakers.

Professional Development:

ISPE is proud to present the workshop Essentials for Leadership Development that will feature key content and highlights of ISPE’s new and upcoming Leadership 101 Program. Participants will be highly engaged in meaningful conversations covering personal leadership, business leadership, and team leadership. Participants will explore and discuss best practices to develop these three aspects of leadership that are highly prevalent in the pharmaceutical industry.

China Forum

As a global organization, ISPE is proud to feature their "China Forum". This enlightening workshop will focus on the dynamic pharmaceutical and healthcare landscape in China. During the session you will be invited to participate in a discussion on the evolution and achievements of ISPE's initiatives in China over the past three years. The session speakers will provide insights and nuanced knowledge between Chinese and USA vaccine regulations, uncovering unique opportunities they present. Explore the burgeoning realm of Gene and Cell Therapy in China, complete with crucial regulatory insights. Gain an understanding of the advancements in biologics manufacturing, emphasizing innovative technologies and robust quality operations. The session also promises a deep dive into the world of Chinese Pharmaceutical Engineering Service. Concluding with a Q&A segment, this workshop offers a comprehensive overview and key takeaways on the pharmaceutical forefront in China.

The 2023 ISPE Annual Meeting & Expo is shaping up to be an extraordinary event that you simply cannot miss. With a record number of workshops being offered on Sunday, conference attendees will have the opportunity to attend two highly engaging and thought-provoking three-hour sessions to start off their Annual Meeting experience. The Program Committee hopes to see you in Las Vegas, Nevada, USA on Sunday, 15 October for this year’s workshops!

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