Attending in-person offers more opportunities for intimate breakouts, roundtable discussions, and networking. Here is what's included:
|Participate in the Pre-Conference Virtual Networking Event.|
|Attend Keynote, Education, & Post-Conference Training Sessions.|
|Attend Industry and Regulatory Panels.|
|Enjoy Breakfast, Coffee, & Lunch in Expo Hall.|
|Access to ALL Education Content On-Demand for 90 Days.|
|Dedicated Expo Hall Hours to Discover the Latest Technology & Products.|
|Mobile App Giveaway Game! Free & Easy to Play with BIG Prizes Available to Win.|
|Interact with Speakers, Panelists, & Attendees|
Network with other attendees and exhibitors, attend the selected live-stream sessions, and identify potential business contacts. Here is what's included:
|Participate in Pre-Conference Virtual Networking Event.|
|View selected Live-streamed Keynotes & Education Sessions & Regulatory Panel Discussions.|
|Access to ALL Education Content On-Demand for 90 days.|
|Chat with Exhibitors in the virtual Expo Hall.|
|Engage with Attendees & Speakers via Chat & Session Q&A.|
Connect with colleagues.
Learn from industry experts.
Grow your network through interactive experiences.
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch.
On Sunday, each hackathon team will present to the panel of Hackathon judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best-proposed solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch.
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:
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:
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.
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.
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.
The content for this workshop gives attendees an overview of the ISPE Leadership 101 program. The ISPE Leadership 101 program is under development and is being designed to be an engaging, 12-month, hands-on experience focusing on 12 essentials for leadership in the pharmaceutical industry.
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.
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 Foundation is excited to announce its second annual golf tournament.
Hosted at Wildhorse Golf Club in Henderson, NV, the Foundation invites you to join us for this event on 19 October 2023.
Proceeds benefit ISPE Foundation
To learn more about registering or sponsoring, contact Tori Johnson, or Barbara Bende.
Take advantage of Deep Dive Pharma Training Courses offered at the 2023 ISPE Annual Meeting & Expo.
Not able to attend live? No worries, this training event will be live streamed.
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.