Conference Experience
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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
- Facility of the Year Awards Celebratory Reception & Banquet
- Welcome and Opening Remarks
- Fireside Chat with Robert Califf, MD & Tom Hartman, ISPE CEO
- Opening Keynote
- The Pursuit of Excellence in Pharmaceutical Therapy
- Science, Patient & the Role Engineering Plays as a Catalyst
- ISPE Southwest Chapter President's Welcome
- ISPE Foundation Greeting
- Be the White Crayon: A Patient Perspective
- Reinventing Partnerships and Medicine for a Healthier World
- Conference Highlights
- ISPE Membership Meeting and Awards Lunch
- Tuesday Keynote Session
- Tuesday Closing Session
- Global Regulatory Town Hall
- Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients
- Wednesday Closing Keynote
- Wednesday Closing Words and Adjournement
Education Sessions
- CSA - Opportunities for GAMP 5 Second Edition and 21 CFR Part 11
- Environmental Sustainability - Operations and Products
- Global Drug Shortage Prevention and Future Directions
- The Holistic Digital Transformation: The Pharma 4.0 Journey
- Design Implementation for Sterile Manufacturing
- Modernizing Regulatory CMC Submissions: Enabling Change
- Innovations and Best Practices in Sustainable Development and Governance
- Transformation into ATMP
- Global Regulator Harmonization Initiatives to Advance Global Application Approvals of Innovative Products, Technologies, and Modalities
- Leveraging Machine Learning (ML) for Enhancing Process, Improving Efficiency, and Maintaining Compliance during Product Manufacturing
- Supply Chain Fragility and the Impact on Patient Care
- ATMP Lifecycle
- The Digital Journey
- Advancements in Drug Development and Equipment Design
- Achieving Net Zero in Pharma Manufacturing
- Updates on ICH Quality Topics: ICH Q12, Q14 and M4Q
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.
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- 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
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- 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.
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- 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.
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- Workshop: China Forum
0900 - 1200This conference workshop provides comprehensive insights into the emerging trends, regulatory differences, and technological advancements in the Chinese pharmaceutical and healthcare sector.
1300 – 1310: Welcome by Ping ZHANG & Sophie PANG
1310 – 1330: Development of ISPE China in recent 3 years by Hongyang LI
1045 – 1115: Differences in Vaccine Regulation:Chinese vs US—- Opportunities by Ping ZHANG
1400 – 1430: Gene and Cell Therapy in China – landscape and regulatory update by Frank GAO
1430 – 1445: Break
1445 – 1515: Manufacturing Excellence on Biologics Products with Single Use Technology and Robust Quality Operations by Sherry GU
1515 – 1545: Introduction of Chinese Pharmaceutical Engineering Service by TBC
1545 – 1600: QA/ClosingSpeakers:
- Workshop: Holistic Digital Pharma 4.0 Maturity Assessment in Pharma 4.0 Conference
- Sunday Social
1600 - 1800Sunday Social
1600 - 1800 | Included with In-Person All Access PassCheck-in, un-wind and enjoy yourself 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!
Attendees of the Sunday Social (up to 150) will receive an exclusive swag bag of ISPE items when visiting the Membership table during the event. These free swag bags are available on a first come first serve basis and are limited to 150. - 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. View Details
Monday, 16 October
- 14th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation (Additional Registration Required)
0600 - 073014th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation
0600 - 0730 | 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.
- Fireside Chat with Robert Califf, MD & Tom Hartman, ISPE CEO
0810 - 0835Fireside Chat with Robert Califf, MD & Tom Hartman, ISPE CEO
0810 - 0835 | Included with In-Person All Access PassWe are thrilled to announce that Robert M. Califf, MD, Commissioner of Food and Drugs at the FDA will be joining ISPE during the 2023 ISPE Annual Meeting & Expo. Commissioner Califf's unique insights and extensive experience in the pharmaceutical and regulatory space promise to shed light on the ongoing challenges and opportunities facing the industry. Don't miss this opportunity to hear firsthand from one of the leading voices in healthcare regulation.
- Welcome & Reception in Expo Hall
1700 – 1900 - Career Center
1700 – 1900Career Center in Expo Hall
Included with In-Person All Access PassJoin us at the ISPE Career Center & Headshot Booth in the EXPO Hall. The ISPE Career Center & Headshot Booth is a one-stop shop for professional development and personal branding resources. Whether you are seeking new employment, looking to advance your career, or simply want to update your headshot, we have something for you.
- ISPE’s Women in Pharma® and Emerging Leaders Networking Event
1930 – 2130The Allure of the Ally, Power and Led by Women in Pharma®
ISPE’s Women in Pharma® and Emerging Leaders Networking Event
2023 ISPE Annual Meeting and Expo
Monday, 16 October 2023 | 1930-2130Presented by:
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 scent off our trail. 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.
Tuesday, 17 October
- ISPE’s Self-Defense Class Powered & Led by Women in Pharma®
0700 - 0800ISPE’s Self-Defense Class Powered & 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 Powered 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.
- Career Center
0915 – 1615Career Center in Expo Hall
Included with In-Person All Access PassJoin us at the ISPE Career Center & Headshot Booth in the EXPO Hall. The ISPE Career Center & Headshot Booth is a one-stop shop for professional development and personal branding resources. Whether you are seeking new employment, looking to advance your career, or simply want to update your headshot, we have something for you.
- Tuesday Night Celebration
1900 - 2200Tuesday Night Celebration
1900 - 2200 | US$225 | Included with In-Person All Access PassIncluded in your In-Person All Access Pass! For all other registrants, the add-on fee for the Tuesday Night Celebration is $225. Join us to experience the best of classic Las Vegas at The Mob Museum. Round trip transportation buses are provided and scheduled to start loading outside the Shark Reef Entrance at 1800, and will begin departing at 1830. There will be food, refreshments, activities, and great networking opportunities with friends and colleagues. You won't want to miss the chance to celebrate the pharmaceutical industry! The celebration starts at approximately 1900.
Wednesday, 18 October
- Career Center
0900 – 1300Career Center in Expo Hall
Included with In-Person All Access PassJoin us at the ISPE Career Center & Headshot Booth in the EXPO Hall. The ISPE Career Center & Headshot Booth is a one-stop shop for professional development and personal branding resources. Whether you are seeking new employment, looking to advance your career, or simply want to update your headshot, we have something for you.
- Global Regulatory Town Hall
0930 - 1045Global Regulatory Town Hall
0930 - 1045 | Included with In-Person All Access Pass and Virtual All Access PassThe Global Regulatory Town Hall will bring together regulators from around the world to provide their insights on current issues such as harmonization of the practical application of standards and regulations at the interface between regulatory inspections and assessments (e.g., adoption of harmonized standards from ICH, PIC/S, etc.). Panelists will also discuss the impact of coordination efforts such as ORBIS and ACCESS on the assessment and approval process.
Thursday, 19 October - Friday, 20 October (After Conference)
- 2nd Annual ISPE Foundation Golf Tournament (Additional Registration Required)
0800 - 14002nd Annual ISPE Foundation Golf Tournament
0800 - 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 Bender.
- 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.
Justify Your Attendance
Help your employer understand how your attendance at the 2023 ISPE Annual Meeting & Expo will be a worthwhile investment. Utilize our customizable justification letter to outline the key benefits you'll attain from attending this educational conference and construct a compelling case for any financial assistance required
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