Conference Experience
One Conference. Two Ways to Attend.
Join colleagues in-person in Las Vegas, NV USA and virtually from anywhere in the world.
In-Person All Access Pass
Attending in-person offers more opportunities for intimate breakouts, roundtable discussions, and networking. Here is what's included:
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Participate in the Pre-Conference Virtual Networking Event. |
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Attend Keynote, Education, & Post-Conference Training Sessions. |
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Attend Industry and Regulatory Panels. |
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Enjoy Breakfast, Coffee, & Lunch in Expo Hall. |
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Access to ALL Education Content On-Demand for 90 Days. |
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Dedicated Expo Hall Hours to Discover the Latest Technology & Products. |
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Mobile App Giveaway Game! Free & Easy to Play with BIG Prizes Available to Win. |
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Interact with Speakers, Panelists, & Attendees |
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Virtual All Access Pass
Network with other attendees and exhibitors, attend the selected live-stream sessions, and identify potential business contacts. Here is what's included:
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Participate in Pre-Conference Virtual Networking Event. |
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View selected Live-streamed Keynotes & Education Sessions & Regulatory Panel Discussions. |
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Access to ALL Education Content On-Demand for 90 days. |
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Chat with Exhibitors in the virtual Expo Hall. |
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Engage with Attendees & Speakers via Chat & Session Q&A. |
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Connect, Learn, Grow
However you choose to attend, ISPE provides you with the best means to connect, learn, and grow your career.
Engagement
Connect with colleagues.
Best Practices
Learn from industry experts.
Collaborative
Grow your network through interactive experiences.
Live Streamed Sessions
General Sessions
- Coming Soon
Education Sessions
- Coming Soon
Featured Networking & Social Events
Saturday, 14 October
- 2023 ISPE International Emerging Leader Hackathon Day 1 (Additional Registration Required)
0800 – 17002023 ISPE International Emerging Leader Hackathon Day 1
0800 – 1700 | Open to Student & Recent Graduate members | Separate Registration is requiredStudents 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.
Sunday, 15 October
- 2023 ISPE International Emerging Leader Hackathon Day 2 (Additional Registration Required)
0800 – 13002023 ISPE International Emerging Leader Hackathon Day 2
0800 – 1300 | Open to Student & Recent Graduate members | Separate Registration is requiredOn 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.
- Workshops
0900 - 1200 & 1300 - 1600Workshops
0900 - 1200 & 1300 - 1600 | Included with In-Person All Access Pass- Workshop: Holistic Digital Pharma 4.0 Maturity Assessment in Pharma 4.0 Conference
0900 - 1200The 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:
- Conduct the Pharma 4.0 MAturity Assessment: Collect data on your organization's digital capabilities, processes, and infrastructure according to the Holistic Pharma 4.0 Maturity Model, and benchmark them against the chosen framework. You can use surveys, interviews, and site visits to gather information.
- Analyze the results: Once you have gathered the data, analyze it to identify gaps and opportunities for improvement. Look for areas where the organization can leverage digital technologies to enhance efficiency, reduce costs, and improve customer experience.
- Develop a roadmap: Based on the results of the assessment, develop a roadmap that outlines the steps needed to improve the organization's digital capabilities. The roadmap should be aligned with the organization's strategic objectives and should prioritize initiatives that deliver the greatest value.
- Implement and monitor progress: Implement the roadmap and monitor progress to ensure that the organization is achieving its digital transformation goals.
Speakers:
- Workshop: OEE and ML for Process Optimization Using Seeq
0900 - 1200The 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:
- Demonstrate techniques to identify downtime and build out OEE metrics to identify production opportunity
- Use machine learning to compare process data to a predefined baseline to isolate the key contributor to process upsets.
Speaker:
- Workshop: Development of a Contamination Control Strategy (CCS)
0900 - 1200According 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.
- Workshop: Designing and Operations of a Flexible Manufacturing Facility
1300 - 1600The 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
Speaker:
- Workshop: ICH Q9(R1) and Quality Risk Management
1300 - 1600This 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.
Speaker:
- Workshop: Essentials for Leadership Development
1300 - 1600The 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.
- Leading Yourself: You will be a good leader to others when you first lead yourself. Leading yourself is about developing the mindset to match your actions.
- Grasping Basic Business Acumen: All businesses generate sales, have operating expenses, and generate bottom-line-financial results. Knowing basic business acumen is the start to leading others to produce a good outcome.
- Communicating Effectively (includes parts of Giving Feedback/ Coaching For Performance): Knowing that different personality types prefer specific communication styles is a key to communicating effectively across your team and with your peers. This includes the ability to give constructive and gentle feedback and coaching skills.
Speaker:
- Workshop: Holistic Digital Pharma 4.0 Maturity Assessment in Pharma 4.0 Conference
- Sunday Social
1500 - 1700Sunday Social
1500 - 1700 | Included with In-Person All Access PassCheck-in, un-wind and relax at the ISPE Sunday Social! Conveniently located on-property, come join us for cocktails, hors d'oeuvres, prizes and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2023 ISPE Annual Meeting & Expo off right!
- Facility of the Year Awards Celebratory Reception & Banquet
1900 - 2200Facility of the Year Awards Celebratory Reception & Banquet
1900 - 2200 | US$250 | Livestream access ONLY is Included In-Person All Access Pass and the Virtual All-Access PassJoin 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 ONLY is 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.
Monday, 16 October
- 14th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation (Additional Registration Required)
0530 - 070014th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation
0530 - 0700 | US$25 | Separate registration and fee are required
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.
- Welcome & Reception in Expo Hall
1700 – 1900 - ISPE’s Women in Pharma® and Emerging Leaders Networking Event
1930 – 2130ISPE’s Women in Pharma® and Emerging Leaders Networking Event
1930 – 2130 | Separate registration is requiredThe 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.
Tuesday, 17 October
- ISPE’s Self-Defense Class, Power & Led by Women in Pharma®
0700 - 0800ISPE’s Self-Defense Class, Power & Led by Women in Pharma®
0700 - 0800 | Separate registration is requiredKick-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.
- Tuesday Night Celebration
1900 - 2200
Wednesday, 18 October
Thursday, 19 October - Friday, 20 October (After Conference)
- 2nd Annual ISPE Foundation Golf Tournament (Additional Registration Required)
0830 - 14002nd Annual ISPE Foundation Golf Tournament
0830 - 1400 | Additional Fees Apply
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.
- In Person or Virtual Training (Additional Registration Required)
0830 - 1630In Person or Virtual Training
0830 - 1630 | Additional Cost ApplyTake advantage of Deep Dive Pharma Training Courses offered at the 2023 ISPE Annual Meeting & Expo.
- GAMP® 5, Annex 11/Part 11 Basic Principles
- GAMP® Data Integrity 21 CFR Part 11
- Commissioning and Qualification
Not able to attend live? No worries, this training event will be live streamed.
Corporate Partner Sponsors
ISPE Membership Benefits
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.
Benefits include:
- Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
- Member-only discounts on Guidance Documents, Conferences, and Training
- Pharmaceutical Engineering® magazine
- Communities of Practice access to pharma professionals in specific topics from around the world
- And more