Conference Experience
One Conference. Two Ways to Attend.
Join colleagues in-person in Orlando, FL 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.
Participate in Pre-conference networking groups & events.
Participate in Post-conference Ask the Experts event.
Attend education sessions.
Access to ALL education content on demand for 90 days.
Visit Expo Hall for the latest technology and products.
Chat with Vendors in the virtual Expo Hall.
Engage with attendees & speakers via chat, polling, and Q&A.
Interact with speakers, panelists, & other attendees.
Virtual All Access Pass
Network with other attendees and exhibitors, arrange meetings, and identify potential business contacts.
Participate in Pre-conference networking groups & events.
Participate in Post-conference Ask the Experts event.
View selected Live-streamed education sessions, all Keynote Sessions, and the Global Regulatory Town Hall.
Access to ALL education content on demand for 90 days.
Chat with Vendors in the virtual Expo Hall.
Engage with attendees & speakers via chat, polling, and Q&A.
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
Plenaries
- Opening & Welcome
- Opening Keynotes Day 1
- Opening Keynotes Day 2
- Member Meeting & Lunch
- Regulatory Presentation & Global Town Hall
- Closing Keynotes
Education Sessions
- Pharma 4.0 - Industry Status & Methodologies
- Recent Developments in Advanced Manufacturing
- GPG Good Engineering Practices at Operation Warp Speed
- GAMP 5 Second Edition - An Overview
- Quality and Regulatory Challenges in ATMPs
- Drug Shortages: Progress in a Challenging Year
- Robust APQ and FDA Quality Management Maturity
- New paradigm for analytical methods - ICH Q2(R2) & Q14
- Blockchain Industry Trends and Use Cases
- Keeping up in the Digital World - A Dive into Validation
- Product Lifecycle, Lifecycle Maturity Model, and Real Time Release testing for BioTech products
- Regulatory Considerations to Boost Innovation and Supply Chain Resilience
Featured Networking & Social Events
Friday, 28 October
- Emerging Leader & Student Hackathon Reception (Additional Registration Required)
1800 – 2000Emerging Leader & Student Hackathon Reception
1800 – 2000 | Open to Student & Recent Graduate membersThis is an in-person networking event for Hackathon Participants, Judges, Coaches, Company Sponsor Representatives, ISPE Board members, and senior leadership. This event will allow the participants and coaches to meet and build a connection before the start of the hackathon. The teams will be assigned and have the opportunity to get acquainted with each other and get a detailed breakdown of the problem statement that will be tackled the next day.
Saturday - Sunday, 29 - 30 October
- International Hackathon (Additional Registration Required)
0800 – 1700International Hackathon
0800 – 1700 | Open to Student & Recent Graduate members | Separate Registration is requiredThe ISPE International Hackathons are events organized by, and for the ISPE Emerging Leaders and Students. The main objective of the Hackathon is to divulge knowledge, in an innovative situation, on the trending topics of the pharmaceutical sector, and to provide and promote networking opportunities between Emerging Leaders, Students, and Senior Industry Experts.
The International ISPE Annual Meeting Hackathon will be held the weekend before the ISPE Annual Meeting & Expo in Orlando, FL, USA at the Gaylord Palms Resort & Convention Center, Orlando, FL, USA
The Emerging Leaders and Students will be divided into multidisciplinary teams. Each team will be tasked with analyzing the problem statement, developing a project charter, and assessing the financial implications of their proposed solutions, with the ultimate goal of pitching to a panel of expert judges at the culmination of the Hackathon. All teams will be assigned a dedicated coach and given access to resources including Pharmaceutical Engineering Magazine and the ISPE Communities of Practice. 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 winners will be announced during the Membership Meeting and Awards Lunch.
Please Note: Registration is only for Emerging Leaders, Students, and Recent Graduates. All conference attendees may observe and there is no need to register for the event.
Sunday, 30 October
- Workshops
0800 - 1600Workshops
0800 - 1600 | Included with In-Person All Access Pass- Workshop: CSA - The Next Steps for Better Compliance
0800 - 1200In this workshop attendees will brainstorm efficiencies and improvements that can be gained through the application of CSA and critical thinking within computerized system lifecycles.
The workshop activities will examine:
- What improvements can CSA and critical thinking bring to computerized system lifecycles and what fundamentals will remain unchanged?
- How critical thinking can become inherent organizationally?
- How to engage leadership, including the quality function, with CSA concepts?
- What metrics and knowledge management practices can quantify and optimize the benefits of CSA in achieving and maintaining computerized systems as fit for intended use?
- How supplier assessments and internal auditing practices need to evolve to maximize leveraging of prior activities?
- What are the barriers to progress and how can they be overcome?
Speaker:
- Workshop: Process Validation - Emerging Challenges and Hot Topics
0900 - 1200This workshop session will address selected hot topics within focused workgroups giving attendees the opportunity to participate in facilitated small group discussions. This format will allow attendees to share experiences or challenges and discuss tools and learnings with colleagues outside of their organization, but with similar interest/experience, bringing a wider understanding of these issues.
Topics/Issues/Challenges for discussion will include PV for products under accelerated development/breakthrough designation; PV for continuous manufacturing; PV applied to emerging/new technology and product platforms; as well as discussions of PV in regions other than US/EU. Drawing from the ISPE PV team, volunteer SMEs will lead the groups and facilitate sharing experiences and thoughts, providing an environment to discuss ideas and strategies to address particular challenges based on experience and knowledge.
Speaker:
- Workshop: Aseptic Compliance Health Check
1300 - 1600In this hands-on workshop, attendees will be provided an example tool to use while the instructors lead them through analyzing examples of aseptic processes and facilities to demonstrate the use of the tool.
The examples are generally drawn from real-life experiences and are chosen to highlight three areas:
- Do legacy processes meet cGMP requirements – for example, are you performing sterile filtration at the filling line?
- Upcoming Annex 1 Requirements – For example, smoke visualization is becoming increasingly used not just for airflow dynamics for clearance rates, etc. but as an integral tool for defining best practices when looking at environmental controls and operator activities. Determine the locations for EM monitoring program (item 4.16 in draft annex 1) and using smoke visualizations as an interactive tool in an aseptic operators training armory (item 7.19 in draft annex 1).
- Hot Topics and Recent Inspection Trends – What recently has come up in the latest inspections?
- Workshop: Career Connections - Developing Your Brand
1300 - 1600
In this workshop, you will learn how to evolve as a leader professional and develop your brand. You will spend the first half of the workshop in an immersive hands-on workshop designed to elevate your personal LinkedIn Profile to the next level. Whether you are looking to build meaningful connections, expand your network, or stand out from the best this workshop will show you tactics to level up your LinkedIn profile.
In the second half of the workshop, will be spent discussing how to create psychological safety allowing you to pursue your leadership potential, expand your confidence, and hone communication skills. We will explore the key components of psychological safety to establish authenticity, allowing for inclusivity to drive a more powerful work experience.
Phil Gerbyshak is a LinkedIn Sales Trainer, Sr. Sales Enablement Program Manager at BambooHR and talk show host ‘Conversations with Phil’ on sales, leadership and digital. He has been doing custom LinkedIn training since 2010. Bring you electronic device to this hands-on workshop to level up your LinkedIn profile. Phil will take you step by step to help your profile stand out. You will learn tactics to leverage your LinkedIn profile to build connections and grow your network, tips to grow your career, and sell your personal brand.
Kara Kirby is a leadership consultant and CEO of Insights Leadership group and podcast host of Pop! On Leadership. She works with companies all over the world to guide their pursuit of being the best places to work. In this session, Kara will be onsite with us to guide our conversations and solve for elements in our organization that hold people back from stepping into their leadership potential. We will look at how to create psychological safety so that the best ideas rise and flourish, honing authenticity, leadership reluctance, and the power of creating a not just diverse but inclusive workforce.Speaker:
- Workshop: CSA - The Next Steps for Better Compliance
- 2022 Facility of the Year Awards Reception and Banquet (Additional Registration Required)
1900 - 22002022 Facility of the Year Awards Reception and Banquet
1900 - 2200 | $250 | Separate registration and fee are required
Join ISPE to celebrate the 2022 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2022 Category winners achievements at ISPE’s premier award presentation ceremony and dinner. Separate ticketed event can be purchased through the registration of ISPE Annual Meeting.
Monday, 31 October
- 13th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation (Additional Registration Required)
0600 – 073013th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation
0600 - 0730 | US$25 | Separate registration and fee are required
Start your day with the 13th Annual ISPE 5K Run/Walk. Join in the competition or enjoy a morning walk watching the sunrise in Orlando, FL.
This year’s 5K event will benefit the ISPE Foundation supporting education, training, and research for the advancement of innovative technologies benefiting patients around the world.
- ISPE’s Career Center
1000 – 1900 - ISPE’s Facility of the Year Award (FOYA) Booth
1000 – 1900ISPE’s Facility of the Year Award (FOYA) Booth
1000 – 1900 | Included with In-Person All Access PassLearn more about the 2022 ISPE’s FOYA winners by visiting the interactive booth on the Expo Floor. You’ll have an opportunity to meet with the winning companies, learn about their projects, and also connect with the FOYA Judges and Committee Volunteers.
- Welcome & Reception in Expo Hall
1700 – 1845 - Emerging Leader & Student Networking Event
1900 - 2100Emerging Leader & Student Networking Event
1900 - 2100 | Open to Student & Recent Graduate membersThis will serve as a celebration of the completion of the hackathon and an opportunity for all Emerging Leaders, and Students that are attending the ISPE Annual Meeting & Expo to network with each other and industry professionals that are involved with Students, Recent Graduates, and/or Emerging Leader Affairs. The Hackathon Committee, Coaches, Judges, and company sponsors will be recognized for their contribution to the planning and execution of the hackathon.
- ISPE’s Women in Pharma Networking Event
1900 - 2100ISPE’s Women in Pharma Networking Event
1900 - 2100 | Included with In-Person All Access PassJoin us for an evening of networking, food, and fun at one of the Gaylord Palms most popular restaurant! Sponsored by ISPE’s Women in Pharma.
Tuesday, 1 November
- ISPE’s Annual Meeting – Yoga
0700– 0800ISPE’s Annual Meeting – Yoga
0700– 0800 | Included with In-Person All Access PassStart your day on the beautiful greens of the Gaylord Palms with the Florida sunshine! Take the stress away with low-impact yoga while connecting with new and old friends. You’ll feel refreshed and ready to start your day.
Sponsored by:
- Membership and Awards Lunch
1215 – 1345Membership and Awards Lunch
1215 - 1345 | Included with In-Person All Access Pass, Virtual All Access Pass and Virtual Essentials PassMeet ISPE leadership and colleagues while learning about significant achievements made by industry in the past year. Celebrate with your peers as the ISPE International Honor Award and the International Student Poster Competition Award winners are presented.
- Tuesday Night Celebration: Hawaiian Luau at Discovery Cove
1900 - 2200
Wednesday, 2 November
- Regulatory Presentation and Global Town Hall
0900 - 1045Regulatory Presentation and Global Town Hall
0900 - 1045 | Included with In-Person All Access Pass and Virtual All Access PassQuality: A Key Ingredient for Stable Pharmaceutical Supply Chains
Speaker: Michael Kopcha, Ph.D., RPh
Patients expect safe and effective medicine with every dose they take. Pharmaceutical quality is what gives patients confidence in their next dose of medicine, but is pharmaceutical quality just one thing? An array of pharmaceutical quality including product quality, process quality, and quality management is necessary to assure that quality issues will not keep a product from being available to patients and consumers--now or in the future. FDA’s initiatives aim to provide everyone with more confidence in their next dose of medicine.
Thursday, 3 November (After Conference)
- 1st Annual ISPE Foundation Golf Tournament (Additional Registration Required)
0830 - 14001st Annual ISPE Foundation Golf Tournament
0830 - 1400 | Additional Fees Apply
Test your golf skills at the 2022 ISPE Annual Meeting & Expo and register for a chance to win a prize.
Thursday, 3 November - Friday, 4 November (After Conference)
- 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 2022 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.
ISPE Safety Precautions
New and robust risk mitigation measures are being undertaken to instill public confidence in the safety of ISPE’s in-person events. In conjunction with the venues and vendors supporting our events, we are committed to the proper implementation of CDC, state, and local public health guidelines to ensure protective measures are in place to help mitigate the spread of COVID-19. Included are the measures ISPE will implement in accordance with the guidelines from the state and local authorities.
Event Sponsors and Supporters
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