PDA Week 2026

The Premier Annual Homecoming Event for the Global Pharma Community

22 - 27 Mar 2026
Denver, CO

Workshops | Training Courses | Educational Sessions | Interest Group Meetings | Networking Opportunities | Exhibit Hall | Honor Awards Ceremony

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Agenda

Discover What's Happening Each Day
Download Full Schedule Please note that this file may take some time to download depending on your internet connection. Thank you for your patience.
Agenda is subject to change. *
Sun 06 Apr Mon 07 Apr Tue 08 Apr Wed 09 Apr Thu 10 Apr Fri 11 Apr Posters 
Sunday, 6 April

MDT Daylight Time (UTC -6:00)

  • PDA Chapter Council Meeting (Invite Only)

  • PDA Advisory Board and Chapter Council Joint Luncheon (Invite Only)

  • PDA Technical Advisory Board (AB) Meetings (Invite Only)

    The four PDA Technical AB meetings taking place during PDA Week 2025 are by invitation only.

    ABs are composed of a diverse group of experts drawn from industry, regulatory agencies, and academia. They provide scientific and technical expertise to the PDA Board of Directors and provide support and guidance for PDA’s scientific, regulatory, and technical initiatives.

  • Presenter Ready Pavilion Open

    Oasis Hall 2

  • Registration Open

    Oasis Hall 2

  • PDA Industry and Honor Awards Ceremony and Dinner (Ticket Required – Cocktail Attire)

    Grand Ballroom (Renaissance)

Monday, 7 April

MDT Daylight Time (UTC -6:00)

  • Morning Wellness Walk

    Departs from Renaissance Lobby

    Rise and refresh!

    Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

    Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

  • PDA Member Lounge Open

    Santa Rosa (Renaissance)

    The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.

  • Registration Open

    Oasis Hall 2

  • Roundtable 1: Speeding Innovation Through Global Regulatory Convergence (Ticket Required)

    Mesquite D

    Join your peers to discover, discuss, and dissect ideas and innovations that could move global regulatory convergence forward to accelerate treatments for patients with terminal illnesses and treatments targeted for future epidemics and pandemics.

  • Roundtable 2: Strategies for Modern Knowledge Management Implementation (Ticket Required)

    Mesquite E

    Management of product and product knowledge plays a critical role across the product lifecycle. However, knowledge management (KM) has not been fully realized in practice. This roundtable will explore the objectives of ICH Q10 and how to best implement KM to the benefit of the industry at large beyond the regulatory expectations.

  • Roundtable 3: Developing the Next Generation of Pharmaceutical Professionals (Ticket Required)

    Mesquite F

    This roundtable will explore strategies for early and mid-career professionals in the biopharmaceutical industry, focusing on skill development, career advancement, mentorship, and navigating industry challenges. Participants will share insights on fostering growth, building networks, and preparing for leadership roles in a dynamic and evolving sector.

  • Roundtable 4: Effective AI Deployment in Drug Manufacturing (Ticket Required)

    Mesquite G

    The integration of Artificial Intelligence (AI) into drug manufacturing is in its early stages, offering both immense opportunities and unique challenges. This roundtable is designed to explore strategies and identify potential barriers such as data quality, system complexity, and workforce readiness. Discussion will also delve into the regulatory landscape and the practical burdens of adopting this transformative technology.

  • Presenter Ready Pavilion Open

    Oasis Hall 2

  • Mini-Workshop: CDMO Selection and Tech Transfer Fundamentals (Ticket Required)

    Mesquite B

    Outsourcing a pharmaceutical project is a strategic decision that has a huge influence on the long-term success of any project. This mini-workshop will focus on the critical steps following the decision to outsource – selecting the right partner for the project and determining technology transfer (TT) requirements. A hands-on exercise on selecting a CDMO (from RFP to scoring criteria) will guide attendees in the thought processes and pathways to select the best partner for the job.

    Workshop Agenda

    • 09:45 | Workshop Welcome
    • 09:50 | Phase Appropriate GMP
    • 10:15 | CDMO Site Selection Hands-On Activity
    • 11:45 | Tech Transfer
    • 12:10 | Workshop Wrap-Up

  • Speed Networking

    Lobby

  • P1: From Manufacturing Excellence to Patient Impact: The Future of GLP-1 Therapies (Oasis Hall 1)

    Oasis Hall 1

    This opening plenary will examine the evolving landscape of GLP-1 therapies as both a market and technology disruption, combining insights into innovative manufacturing advancements alongside the important patient perspective. The presenters will explore how disruptive technologies are transforming the production of GLP-1 products, ensuring greater efficiency and quality, while also addressing the real-world impact of these therapies on patients’ everyday lives. The discussion will highlight opportunities to improve outcomes through collaboration between manufacturers, healthcare professionals, patients, and their providers.

  • Networking Break

    Lobby

  • A1: Disruptive Therapies (Primrose A)

    Primrose A

    This session will explore cutting-edge developments and new modalities in the ATMP or biopharmaceutical space. Experts will share insights into these emerging technologies, highlighting challenges, risks, opportunities, and best practices for bringing next-generation therapies to market.

  • B1: Innovative Pharmaceutical Manufacturing Solutions (Primrose B)

    Primrose B

    This session will focus on innovative approaches addressing modern pharmaceutical manufacturing challenges. Discussions will cover the justification and execution of simulated leachables testing when drug products are unavailable, the development of sustainable modular platforms for small batch production, and strategies for designing automation to meet stringent regulatory and quality standards. Through case studies and actionable guidance, attendees will learn how to align manufacturing innovations with compliance and quality objectives.

  • C1: Enhancing Quality Maturity (Primrose C)

    Primrose C

    This session will explore strategies and tools to elevate quality maturity in pharmaceutical manufacturing. Topics will include selecting impactful key performance indicators (KPIs) to drive positive organizational outcomes, leveraging collaborative technologies to enhance root cause analysis effectiveness, and using innovative inspection intelligence tools to prepare for regulatory inspections of sterile products. Through case studies and expert insights, attendees will gain practical approaches to integrating quality principles with manufacturing excellence.

  • D1: Ready, Set, Prep: Practical Tools for Audits and QRM/CMC Strategies in Contamination Control (Primrose D)

    Primrose D

    This session will explore effective preparation strategies for GxP audits and inspections, including mock inspections and past audit reviews, while gaining insight into integrated CMC strategy and quality risk management (QRM) for contamination control. Participants will hear practical insights for getting audit-ready and learn new models for effective risk-based approaches, ensuring robust compliance and patient safety.

  • Grand Opening Happy Hour in the Exhibit Hall

    Oasis Hall 3-4

  • Opening Reception

    Jackie Lee Houston Plaza

    Immediately following the Grand Opening Happy Hour in the Exhibit Hall, keep the good vibes going outdoors under the Palm Springs night sky at the PDA Week 2025 Opening Reception! Join us Monday night for a mix of great beats, good eats, and even better company as we turn up the volume on networking.

    • A DJ spinning the perfect soundtrack
    • Refreshing drinks and tasty bites to keep you fueled
    • Networking that hits all the right notes
    • A laid-back, festival-style atmosphere—your PDA Week badge is your all-access pass!

    Whether you’re here to make industry moves, vibe with colleagues, or just enjoy the desert night, this reception is music to your ears! Don’t miss out—let’s get PDA Week 2025 started on a high note!

    The Opening Reception is included for all full meeting registrants and exhibitors. Guest tickets are available for purchase for $75.
Tuesday, 8 April

MDT Daylight Time (UTC -6:00)

  • Morning Wellness Walk

    Departs from Renaissance Lobby

    Rise and refresh!

    Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

    Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

  • PDA Member Lounge Open

    Santa Rosa (Renaissance)

    The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.

  • Continental Breakfast

    Lobby

  • Registration Open

    Oasis Hall 2

  • Presenter Ready Pavilion Open

    Oasis Hall 2

  • P2: Sustainability at Scale: Transforming Facilities and Mindsets in Pharma (Oasis Hall 1)

    Oasis Hall 1

    Pharmaceutical manufacturing is one of the industries leading the charge toward a sustainable future and setting a new standard for environmental responsibility. In this plenary session, Jane Zhang will illustrate how procurement and supply chain innovation will drive transformative behavioral change within organizations. Phil Duncanson will unveil AstraZeneca’s ambitious sustainability journey, from modernizing aging facilities to creating a groundbreaking carbon-neutral site in Singapore. Attendees will gain actionable strategies to champion sustainability as a cornerstone of industry progress.

  • Networking Break in the Exhibit Hall (Oasis Hall 3-4)

    Oasis Hall 3-4

  • PDA Press Conference

    Mesquite G

  • Exhibit Hall Open

    Oasis Hall 3-4

  • A2: Data Management and Lifecycle Strategies for Advanced Therapies (Primrose A)

    Primrose A

    This session will examine cutting-edge approaches to data management and lifecycle strategies in ATMP and biopharmaceutical manufacturing. Topics will include optimizing digital ecosystems for patient traceability, transitioning from batch to campaign filling modes, and leveraging pharmaceutical continuous manufacturing (PCM) for lifecycle management. Attendees will gain insights into integrating data-driven strategies with regulatory frameworks to enhance efficiency, compliance, and scalability.

  • B2: Advancing Quality Control: Automated Visual Inspection in Parenterals (Primrose B)

    Primrose B

    This session will explore cutting-edge advancements in automated visual inspection (AVI) for parenterals. Topics will include lifecycle and risk management for visible particles, reducing false rejects using data analytics and machine learning (ML), and a novel human-inspired inspection approach. Attendees will leave this session with enhanced knowledge of improving accuracy, efficiency, and compliance in AVI systems.

  • C2: Digital Transformation (Primrose C)

    Primrose C

    This session will delve into the impact of digital transformation on biopharmaceutical processes, highlighting innovations in contamination control, risk management in fill-finish, and streamlining technology transfers. Experts will discuss how digital tools are driving efficiency, reducing risk, and ensuring compliance across the manufacturing lifecycle.

  • D2: Regulatory Insights and Challenges: Annex 1, PUPSIT, and Drug Compounding (Primrose D)

    Primrose D

    This session will address key regulatory challenges impacting the pharmaceutical industry. Topics will include insights from the Kilmer Community PUPSIT survey post-Annex 1 implementation, the evolving regulatory framework for compounded drugs, and findings from the PDA Annex 1 survey. Attendees will gain a deeper understanding of regulatory trends, compliance strategies, and their implications for patient safety.

  • Networking Lunch in the Exhibit Hall (Oasis Hall 3-4)

    Oasis Hall 3-4

    • Poster Presentations and Voting

    • Technical Report Live | PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

  • Exhibitor Tech Talks (Oasis Hall 3-4)

    Oasis Hall 3-4

  • IG01: Combination Products

    Primrose A

  • IG02: Drug Compounding

    Primrose C

  • IG03: Management of Outsourced Operations and Technology Transfer

    Primrose D

  • IG04: Quality Risk Management and Supply Chain Management

    Primrose B

  • Mini-Training Course 1: Lyophilization (Ticket Required)

    Mesquite A

    This mini-training course will help participants gain an understanding of the basic principles and practical aspects of lyophilization technology. Attendees will learn about the process and equipment, vacuum technology use for freeze drying, solidification during freezing, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics, and process scale-up to production.

  • Transition to Next Interest Group

  • IG05: Data Governance, Management, Integrity, and Digitalization

    Primrose A

  • IG06: Microbiology/Environmental Monitoring

    Primrose D

  • IG07: Process Validation

    Primrose C

  • IG08: Sterile Processing/Parenteral Drug Manufacturing

    Primrose B

  • Lightning Session 1 (Mesquite B)

    Mesquite B

    PDA's Lightning Presentations will use the Pecha Kucha presentation method, which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of 6 minutes and 40 seconds.

  • Networking Break in the Exhibit Hall (Oasis Hall 3-4)

    Oasis Hall 3-4

  • A3: CMC Insights for Biosimilars and Container Closure Integrity Testing Advancements (Primrose A)

    Primrose A

    This session will explore key aspects of CMC for biosimilars, including clone selection, manufacturing processes, and comparative assessments. It will address upcoming challenges in container closure integrity testing (CCIT) for low-temperature containers, biopharmaceutical compatibility, and delivery systems. Attendees will also learn about future innovations in CCIT and automated visual inspection (AVI) integration for automated, high-throughput inspection of low-volume solutions.

  • B3: Transforming Contamination Control: Innovative Strategies, Technologies, and Risk Management (Primrose B)

    Primrose B

    Contamination control remains critical to pharmaceutical manufacturing, with innovations and methodologies aimed at addressing regulatory compliance challenges and enhancing operational efficiency. This session will delve into real-time microbial monitoring using biofluorescence particle counters, environmental control and monitoring driven by quality risk management (QRM), and approaches to modernizing legacy systems through process modeling and AI-enabled automation. Each presenter will provide actionable insights and practical strategies for contamination control optimization.

  • C3: Applied Artificial Intelligence (Primrose C)

    Primrose C

    Over the past decade, artificial intelligence (AI) has seen exponential growth throughout various industries. While we have seen a slower adoption rate in the biopharmaceutical industry, we are coming to an inflection point. In this session, participants will look at the different ways AI is being implemented in our industry within our current regulations.

  • D3: Proactive Data, Quality, and Risk Management for Business Sustainability (Primrose D)

    Primrose D

    This session will explore the power of proactive data, quality, and risk management to achieve business sustainability in the pharmaceutical industry. Topics will include developing data and risk management driven strategies for supply chain resilience, leveraging quality risk management to achieve operational excellence and business growth, and utilizing advanced graph-based intelligence for quality assurance to increase business competitiveness. Attendees will gain actionable insights into aligning quality processes with business success and sustainability.

  • PDA Member Lounge Open

    Santa Rosa (Renaissance)

    The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.

  • Supplier Think Tank: Aizon (Free for PDA Week Attendees - Advance Sign Up Required)

    Chino (Renaissance)

    Be part of a dynamic discussion where suppliers, innovators, and experts unite to explore strategies, trends, and solutions that matter most. Let’s shape the future of our industry—together.

    Ready to see real results from AI in pharma? Digital transformation in pharma often fails to deliver results where it matters most: the shop floor. Too many initiatives are pharaonic and disconnected from business outcomes. In this session, Geri Studebaker, CCO at Aizon and a transformational leader dedicated to enhancing global health through innovative business strategies, will reveal how GxP compliant AI can break that pattern: reducing downtime, improving yield, and accelerating value in just 100 days. Expect a dynamic discussion grounded in real-world application, not theory.

    By signing up for this Think Tank, participants understand that their contact information will be shared with Aizon.

    Aizon Think Tank Sign Up—Free for PDA Week Attendees

  • Architecture and Celebrity Homes Bicycle Tour (Ticket Required)

    Departs from Renaissance Lobby

    Riders will get a unique glimpse into Palm Springs’ Hollywood history, architectural masterpieces, and destination highlights. The biking route includes the historic Palm Springs neighborhoods where riders will see examples of key architects important to the development of Palm Springs in the 1950s and 1960s as well as several celebrity homes.

    Bicycles and helmets (required) will be provided.

  • Bar Trivia + Local Beer Tasting and Dinner (Ticket Required)

    Departs from Renaissance Lobby

    La Quinta Brewing Co. opened their doors in the fall of 2013 and has become a destination spot with continued growth in popularity. Participants will be broken up into teams for rounds of trivia. In between trivia, participants will enjoy a delicious taco/nacho bar with chicken, beef, and vegetarian options with their choice of four (4) different 5 oz beers to taste from La Quinta Brewing Co.’s rotating selection of IPAs, porters, lagers, ales, wheat, and special seasonal beers. A docent will be present to walk you through the beer tastings. Don’t miss your opportunity to enjoy the laid-back desert lifestyle of Palm Springs while sipping craft beer with friends!

    • Price: $70 per person – includes trivia, beer flight, and taco/nacho bar
    • Tickets: 40 max.
    • Start: 18:15 PT – participants to meet in the Renaissance hotel lobby to walk to brewery together (approx. 0.8 m/1.3 km) – group will depart from the hotel lobby promptly at 18:30 PT
    • End: 20:00 PT – participants can return to their hotels at their leisure
    • Note: All participants must be at least 21 years old. Comfortable shoes and a light layer are recommended.

  • Palm Springs Aerial Tram and Dinner (Ticket Required)

    Departs from Renaissance Lobby

    The Palm Springs Aerial Tramway has the world’s largest rotating tram car and travels over 2.5 mi/4 km along the cliffs of Chino Canyon, transporting visitors to the pristine wilderness of the Mt. San Jacinto State Park and Wilderness Area. During the 10-min journey, tram cars rotate slowly, offering spectacular views of the valley below. At the tram’s Mountain Station (elevation 8,516 ft/2,596 m and 30°F cooler than the desert floor), guests will enjoy 180-degree views of the valley from the observation decks, watch two documentary films, visit the natural history museum, and enjoy dinner at Peaks Restaurant. This trek to the top of this famous mountain is truly a singular experience!

    Dinner includes your choice of an appetizer, an entrée with two sides, and a soft drink or water. Alcohol is available for purchase.

    • Price: $180 per person – includes tram ticket, dinner, and roundtrip transportation
    • Tickets: 50 max.
    • Start: 18:15 PT – participants to meet in the Renaissance hotel lobby to board the bus that will depart promptly at 18:30 PT
    • End: 21:30 PT – participants will ride the bus back to the Renaissance hotel
    • Note: The temperature at the Mountain Station can be up to 30°F cooler than in the valley, so a jacket and comfortable walking shoes are recommended. Participants will select from the following menu options:
      • Appetizers
        • Charred shrimp
        • Mediterranean bruschetta
      • Entrées
        • Pan Seared Salmon served with mango salsa, jasmine rice, and baby bok choy
        • Wild Mushroom Ravioli in a porcini cream sauce
        • Roasted half duck served with jasmine rice, baby bok choy, and blackberry gastrique
        • Filet of beef in a demi glaze served with red bliss potato puree and baby carrots

  • Wine and Watercolors (Ticket Required)

    San Jacinto (Renaissance)

    Calling all artists for this fun and unique experience! Participants will craft beautiful greeting cards with watercolor paints while enjoying their choice of two (2) drinks (wine or beer) and a charcuterie board to snack on. Professional instruction and all supplies to make four (4) greeting cards per person will be provided (cards, pens, paints, brushes, and aprons).

    • Price: $110 per person – includes two (2) glasses of wine or beer, charcuterie, professional watercolor painting instruction, and supplies
    • Tickets: 50 max.
    • Start: 18:30 PT – event will take place at the Renaissance hotel
    • End: 20:30 PT
    • Note: All participants must be at least 21 years old.
Wednesday, 9 April

MDT Daylight Time (UTC -6:00)

Thursday, 10 April

MDT Daylight Time (UTC -6:00)

  • Morning Wellness Walk

    Departs from Renaissance Lobby

    Rise and refresh!

    Start your day with a refreshing Morning Wellness Walk from 06:00-06:30 in beautiful Palm Springs. Enjoy the crisp desert air, take in the stunning sunrise, and connect with fellow attendees on a light, invigorating outing. It’s the perfect way to energize your mind and body before a full day of learning and networking. All fitness levels welcome, and participation is free!

    Meet in the Renaissance Lobby—walkers will depart promptly at 6:00 AM. After your morning stroll, stop by the PDA Member Lounge for a well-earned cup of coffee!

  • PDA D/A/CH Chapter: Opportunities and Challenges for Start Ups Webinar

    Santa Rosa (Renaissance)

    Join the PDA D/A/CH Chapter Thursday, 10 April for coffee and connections at PDA Week 2025! Gather in person to watch the Chapter’s Opportunities and Challenges for Start Ups webinar live, then stay to network and exchange ideas with fellow professionals. All PDA members, regardless of chapter, are welcome! Coffee and tea will be provided—please sign up in advance.

    • Where: PDA Member Lounge at the Renaissance Hotel
    • When: Thursday, 10 April, 07:00-08:30 PDT
    • Cost: Free!
    • Attend In Person at PDA Week 2025: Advance Sign Up

    Join us for an engaging conversation where we will explore three captivating stories of innovation in biotechnology and IT. Are you aware of the key differences between launching a new business idea in the biotech or IT sectors in the USA and Germany?

    Discover the contrasting approaches to launching new business ideas in Germany and the USA. Whether you choose to join us online or attend in person at PDA Week 2025 in Palm Springs, CA, this is a conversation you won't want to miss.

    Meet the Presenters

    • Lara Denk, a Master's student in Economics at Ludwig Maximilian University (LMU) in Munich, will present insights on this topic.
    • Bianca Bohrer, CEO of PSM, a German CDMO, will discuss her experiences setting up a new Contract Development and Manufacturing Organization (CDMO) service that provides a comprehensive range of solutions from API to sterile pharmaceutical products, including the hurdles she faced.
    • Svetlana Kiseleva, CPO and Co-Founder of Plair SA will introduce new technologies for manufacturing sterile medicines, specifically focusing on a Biofluorescent Particle Counter (BFPC) that aims to replace traditional monitoring methods using settle plates.

    The webinar will conclude with an interactive session discussing how the PDA D/A/CH Chapter can support startups and accelerate the adoption of innovative technologies in the market.

    We look forward to seeing you there!

  • PDA Member Lounge Open

    Santa Rosa (Renaissance)

    The member lounge is a spacious and inviting area designed for relaxation and socializing among PDA members. Members can enjoy coffee and refreshments while engaging in conversations. The lounge is a vibrant hub for networking, community-building and member recognition. With free Wi-Fi and charging stations available, it's the perfect spot to unwind or collaborate with fellow members.

  • Registration Open

    San Jacinto (Renaissance)

  • Aseptic Processing Essentials Workshop - Separate Registration Required (Pueblo - Renaissance)

    Pueblo (Renaissance)

    This workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The workshop will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

    Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

    Workshop Information and Registration

  • Contamination Control Strategy Essentials Workshop - Separate Registration Required (Chino - Renaissance)

    Chino (Renaissance)

    Learn not only the theory of developing a great contamination control strategy (CCS), but also how to translate that theory into actual practice. Gain the skills you need to create holistic contamination control strategies covering all aspects of the manufacturing operation, including facility design and utilities, environmental control, validation and monitoring, quality systems, people, and processes.

    This workshop is based on the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing, which will be provided free to each participant as a tool to prepare for the workshop. Jumpstart your CCS understanding and how to apply it to your manufacturing facilities and processes in this world-class interactive workshop – your hands-on solution to developing and implementing a successful CCS!

    Workshop Information and Registration
Friday, 11 April

MDT Daylight Time (UTC -6:00)

  • Registration Open

    San Jacinto (Renaissance)

  • Fundamentals of Quality Risk Management Training Course - Separate Registration Required (Chino - Renaissance)

    Chino (Renaissance)

    This training course will provide an overview of the quality risk management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

    This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

    Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

    Training Course Information and Registration

A Comparative Study of Polysorbate Adsorption to Membrane Filters for Fill & Finish Applications, Considering a Potentially Upcoming Restriction of the use of PFAS Based Membranes, such as PVDF
Mariam Salamatian, MS, Senior Scientist, Sartorius

A Novel Automated Approach to Surface Swab Sampling
Linda Long, Director, Hyde Engineering and Consulting

A Quality by Design Approach to Microbial Retention Validation
Annie Leahy, MS, MSAT Manager, MilliporeSigma

A Quality by Design Approach to Microbial Retention Validation
Miao Wang, PhD, Principal Scientist, Bristol Myers Squibb

Addressing the Workforce Shortage: A Collaborative Approach to GMP Programs for Building a Skilled Pharma and Biotech Talent Pipeline
Christian Spiak, Principal Consultant - Human Performance, CAI

Bacterial Endotoxins Testing Using Non-Animal Derived Reagents and Innovative Microfluidic Technology on Real World Samples
Hayden Skalski, Global Applications Specialist, Sievers Instruments - Veolia WTS

Beyond Quality Culture: Fostering a Holistic Work Environment
Kumbirai Dhliwayo, MS, Founder & Principal Consultant, Kumby Consulting

Comparison of Small Virus Clearance and Flowrates Between Meissner’s SepraPor® Hollow Fiber Ultrafiltration 50 kDa and 500 kDa Filter Membranes Using ΦX174 Bacteriophage
Zachary A. Bendiks, PhD, Senior Scientist, Meissner Corporation

ebeam Technology – Annex 1 Compliant Transfer of Ready To Use Objects
Merritt Postma, Executive Director North American Sale, SKAN

Effect of Lyophilization on the Concentration and Recovery of Potential Leachables in Different Matrices Simulating Biological Media
Gisele Coelho, PhD Student, Université Paris-Saclay

Ensuring Data Integrity in Digitalized Manufacturing: Risk-Based Strategies for Achieving GxP Compliance
Peniel Ortega, PMP, Managing Director, PharmAllies

Equipment and Process Validation for an Industrial VH2O2 Sterilization Application
Mary Van Gaasbeck Carico, Technical Sales Specialist, Life Sciences Equipment and Service, STERIS Corporation

High-Speed Radiographic Analysis of Subcutaneous Injection Depots: Dispersion, Morphology, and Diffusion in Autoinjector Delivery
Rozhin Derakhshandeh, PhD Student, Research Assistant, Purdue University

Image-Based Culture Plate Readers and Microbiological Testing of Mixtures - is it Necessary?
Chris Ramsey, PhD, Busines Development Director, Clever Culture Systems

Implementation of Barrier Systems - Where is the A Team?
Marsha L. Steed, CEO & Founder/Expert SA Consultant, Steed MicroBio

Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success
Anthony Stewart, Senior Process Engineer, Biologics & ATMP, Kymanox

Incorporating AI into the Process Validation Lifecycle: A Two-Way Street
Alyssa Burke, Senior Validation Engineer, BW Design Group

International Technology Transfers: A Playbook for Success
Priscilla Pingrey, Director of Engineering Programs, Sequoia Biotech Consulting

Kite Pharma R&D Quality Internship
Devon Cooper, Graduate Student, Keck Graduate Institute

Material and Packaging Selection and Compatibility with Chlorine Dioxide Gas Sterilization
Emily Lorcheim, MBA, PMP, VP Sterilization Technologies, ClorDiSys

Maximizing Gene Therapy Doses for Patients
Peter Gegusch, Technical Sales Manager, Optima

Microbial Control for Nonsterile Drug Manufacturing Product Contact Surfaces
Antonio Ortiz, MS, Technical Services Manager, STERIS

NeoFlexTM Plunger Platform: A Focus on Large Volume Plungers for Autoinjector and Wearable Devices
Yitian Xiao, Technical and Scientific Expert, Datwyler Pharma Packaging, USA

Next GEN Pharma Machinery - Flexible Fill and Finish
Jeurgen Metzger, Director of Turnkey Projects & New Technologies, Bausch+Ströbel

Process Validation for Lyophilized Drug Products: Comparing a Program for Continued Process Verification in Different Lyophilized Products
Abirami Natesh, Quality Assurance Associate, Lyophilization Technology, Inc.

Regulatory Data Insights and Methods of Extraction and Analysis
George Kwiecinski, CEO, Global Key Solutions Corp.

Strategy to Evaluate Performance of Lyophilization Stoppers
Sonia Adamidis, MS, MBA, Senior Technical Account Specialist, West Pharmaceutical Services

The Next Step in the Journey to a Full Electronic Quality Management System (EQMS) in the Irish Blood Transfusion Service
Rebecca Walden, MSc, FIBMS, FAMLS, CSci, Senior Quality Systems Specialist, Irish Blood Transfusion Service

Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook
Jerry Tischler, Sr. Staff Quality Specialist, Sequoia Biotech Consulting

Program Planning Committee

The Team Behind the Event's Agenda

  • Yeissa M. Chabrier-Rosello, PhD

    U.S. FDA

    Senior Pharmaceutical Quality Assessor, OPQ, CDER

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  • Jennifer Cheung

    Gilead Sciences

    VP of Global Quality Assurance Operations

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  • Stephanie N. Lee, MBS, PMP

    Amgen

    Strategic Planning & Operations Manager

    Read Bio

  • Peter J. Makowenskyj, MEng

    G-CON

    Director of Design Consulting

    Read Bio

  • Ryan Murray, MS

    ValSource, Inc.

    Senior Consultant

    Read Bio

  • Ken Paddock

    Merz Aesthetics

    Director, Global Quality Sterility Assurance

    Read Bio

  • Malav Parikh, ME

    Takeda

    Director, Quality Risk Management, Global Quality Compliance and Systems

    Read Bio

  • Divyang Patel

    AtkinsRéalis

    Senior Consultant & Project Manager

    Read Bio

  • Julian Petersen

    Groninger

    Head of Business Development

    Read Bio

  • Sebastian B Teitz, PhD

    Novo Nordisk

    Senior Development Scientist

    Read Bio

  • Robin Usselman

    PBL (Performing Beyond Limits)

    Sr. Business Development Manager, USA & Canada

    Read Bio

  • Vanessa Vasadi Figueroa, MA

    VVF Science

    Chief Microbiologist

    Read Bio

Promotions and Press

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Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


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Registration

Pricing Options

More information coming soon.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Presenters

Meet the Experts
  • Sam Albeke

    Sam Albeke

    Element Materials Technology

    Chromatography Manager

    Presenter
    Read Bio
  • Maria Amaya, PhD

    Maria Amaya, PhD

    Genentech

    Lead External Advocacy North America (Quality Policy)

    Interest Group Leader
    Trainer
    Read Bio
  • Henry Ames, MBA

    Henry Ames, MBA

    TraceLink

    General Manager, Logistics Orchestration

    Interest Group Leader
    Read Bio
  • Arie Anahory, MS

    Arie Anahory, MS

    Regulatory Compliance Associates Inc.

    Global Head of Operations

    Interest Group Leader
    Read Bio
  • Erik Anderson

    Erik Anderson

    Novavax

    Principal Engineer

    Presenter
    Read Bio
  • Virginia Andreotti-Jones

    Virginia Andreotti-Jones

    ValSource, Inc.

    Consultant, Quality Risk Management

    Presenter
    Trainer
    Read Bio
  • Frederic B. Ayers

    Frederic B. Ayers

    ValSource, Inc.

    Senior Consultant - Microbiology

    Trainer
    Read Bio
  • Tiffany A. Baker, MBA

    Tiffany A. Baker, MBA

    ValSource, Inc.

    Senior Consultant

    Trainer
    Read Bio
  • Adithya Balasubramanian, MS

    Adithya Balasubramanian, MS

    ten23 health

    Director

    Presenter
    Read Bio
  • Maggie Bandel, MBA

    Maggie Bandel, MBA

    Johnson & Johnson

    Global Head Lifecycle Management ATSC MSAT

    Interest Group Leader
    Read Bio
  • Marcia C. Baroni, MBA

    Marcia C. Baroni, MBA

    Emergent BioSolutions

    VP Quality, Enterprise GxP Compliance & Systems

    Interest Group Leader
    Presenter
    Read Bio
  • Hal Baseman, MBA

    Hal Baseman, MBA

    ValSource, Inc.

    Vice President

    Trainer
    Read Bio
  • Darren Beckett

    Darren Beckett

    Fedegari Technologies, Inc.

    Sr. Training and Technology Center Manager

    Presenter
    Read Bio
  • Brian Bosso

    Brian Bosso

    STERIS

    Technical Service Manager

    Presenter
    Read Bio
  • Mitchell J. Brasher

    Mitchell J. Brasher

    Gerresheimer

    Global Product Manager

    Tech Talk Presenter
    Read Bio
  • Kurt A. Brorson, PhD

    Kurt A. Brorson, PhD

    PAREXEL

    Vice President Technical

    Presenter
    Read Bio
  • Antonio Burazer

    Antonio Burazer

    Takeda

    Global Head Visual Inspection & Particle LCM

    Presenter
    Read Bio
  • Cristiana Campa, PhD

    Cristiana Campa, PhD

    GSK

    Technical R&D Advisor

    Discussion Leader
    Interest Group Leader
    Trainer
    Read Bio
  • Yeissa M. Chabrier-Rosello, PhD

    Yeissa M. Chabrier-Rosello, PhD

    U.S. FDA

    Senior Pharmaceutical Quality Assessor, OPQ, CDER

    Committee Member
    Read Bio
  • Andrew C. Chang, PhD

    Andrew C. Chang, PhD

    Novo Nordisk

    Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence

    Panelist
    Presenter
    Read Bio
  • Jennifer Cheung

    Jennifer Cheung

    Gilead Sciences

    VP of Global Quality Assurance Operations

    Committee Member
    Moderator
    Read Bio
  • Michael de la Torre

    Michael de la Torre

    Redica Systems

    CEO

    Presenter
    Read Bio
  • Maxwell De Long, MS, MechE

    Maxwell De Long, MS, MechE

    Genentech

    Director and Senior Principal, Individualized Medicines

    Trainer
    Read Bio
  • Michael J. Dingle

    Michael J. Dingle

    TSI

    Senior Product Specialist

    Presenter
    Read Bio
  • Samuel Dorey, PhD

    Samuel Dorey, PhD

    Sartorius Stedim Biotech

    Principal Scientist Materials & Irradiation

    Presenter
    Read Bio
  • Robert Dream

    Robert Dream

    HDR Company

    Managing Director

    Interest Group Leader
    Read Bio
  • Phil Duncanson, PhD

    Phil Duncanson, PhD

    AstraZeneca

    Senior Director, Global Quality Control

    Presenter
    Read Bio
  • Arnaud Fournier

    Arnaud Fournier

    Aptar Pharma

    Regional Market Development Manager

    Tech Talk Presenter
    Read Bio
  • Mirko Gabriele, PhD

    Mirko Gabriele, PhD

    InfiniteVision

    CEO

    Interest Group Leader
    Read Bio
  • Jeffrey Gensler

    Jeffrey Gensler

    Kindeva Drug Delivery

    VP Quality

    Presenter
    Read Bio
  • Kellen Giroux, CQA, CQE

    Kellen Giroux, CQA, CQE

    Network Partners Group

    Director, Quality Solutions

    Presenter
    Read Bio
  • Mauro Giusti, MSc

    Mauro Giusti, MSc

    Eli Lilly and Company

    Senior Director, Parenteral Technical Knowledge

    Interest Group Leader
    Read Bio
  • Berwald Gomes, MSc

    Berwald Gomes, MSc

    Roche

    Vision Engineer/Engineer Optical Control

    Presenter
    Read Bio
  • Yowvanaraj Gopal

    Yowvanaraj Gopal

    ValGenesis

    Director Professional Services

    Presenter
    Read Bio
  • Karen Granzow

    Karen Granzow

    Koerber Pharma, North America

    Senior Consultant

    Tech Talk Presenter

  • Yvonne Groß, Dipl.-Ing

    Sartorius Stedim Biotech

    Senior Scientist

    Presenter
    Read Bio
  • Raj Gulati, MPharm, MBA, MS

    Raj Gulati, MPharm, MBA, MS

    Regunalys

    Founder & CEO

    Presenter
    Read Bio
  • Shanker Gupta, PhD

    Shanker Gupta, PhD

    PDA Journal of Pharmaceutical Science and Technology

    Editor-In-Chief

    Presenter
    Read Bio
  • Ghada N. Haddad, PhD

    Ghada N. Haddad, PhD

    Merck & Co., Inc.

    Executive Director, Global Quality Transformation

    Interest Group Leader
    Panelist
    Read Bio
  • Wendy Haines, PhD

    Wendy Haines, PhD

    Toxicology Allies

    President & Lead Toxicologist

    Presenter
    Read Bio
  • Ashley Harp, PE

    Ashley Harp, PE

    CRB

    Process Engineer

    Presenter
    Read Bio
  • Kir F. Henrici

    Kir F. Henrici

    The Henrici Group

    Chief Executive Officer

    Interest Group Leader
    Read Bio
  • Joseph Horvath, PhD

    Joseph Horvath, PhD

    Takeda

    Head, Global Quality Risk Management

    Presenter
    Read Bio
  • Kurt Jaecques, MA

    Kurt Jaecques, MA

    GSK

    Global Quality Technical Senior Lead

    Interest Group Leader
    Read Bio
  • Richard Jaenisch, MPH

    Richard Jaenisch, MPH

    Open Biopharma Research and Training Institute

    Director of Education and Outreach

    Presenter
    Read Bio
  • Rebecca D. Jordan

    Rebecca D. Jordan

    Bristol Myers Squibb

    Director, Global Cell Therapy Sterility Assurance Lead

    Interest Group Leader
    Read Bio
  • Maik W. Jornitz

    Maik W. Jornitz

    BioProcess Resources

    Principal Consultant

    Interest Group Leader
    Presenter
    Read Bio
  • Matthias Kahl

    Matthias Kahl

    WILCO AG

    Head of R&D and Lab Services

    Presenter
    Read Bio
  • Manny Khera

    Manny Khera

    Cytiva

    Head of Engineering - Aseptic Filling

    Presenter
    Read Bio
  • Dan A. Klein, MA

    Dan A. Klein, MA

    STERIS

    Senior Technical Service Manager

    Presenter
    Read Bio
  • Ulrich Koellisch, PhD

    Ulrich Koellisch, PhD

    GxP-CC

    Partner

    Interest Group Leader
    Presenter
    Read Bio
  • Judith Koliwer, PhD

    Judith Koliwer, PhD

    Körber Pharma Software

    Senior Industry Advisor & Principal Consultant Advanced Therapies

    Presenter
    Read Bio
  • Elizabeth Kramer, PhD

    Elizabeth Kramer, PhD

    Eli Lilly and Company

    Senior Director

    Interest Group Leader
    Read Bio
  • Thomas Kroc, PhD

    Thomas Kroc, PhD

    International Irradiation Association

    US Representative

    Presenter
    Read Bio
  • Stephanie P. Kurtz, MS

    Stephanie P. Kurtz, MS

    Modular Devices Cleanrooms

    Technical Cleanroom Sales Account Executive

    Discussion Leader
    Read Bio
  • Stephen E. Langille, PhD

    Stephen E. Langille, PhD

    ValSource, Inc.

    Senior Microbiology Consultant

    Interest Group Leader
    Read Bio
  • Grace Lee, PhD, MBA, CQA

    Grace Lee, PhD, MBA, CQA

    Elevalue Consulting LLC

    Founder and Principal Consultant

    Presenter
    Read Bio
  • Stephanie N. Lee, MBS, PMP

    Stephanie N. Lee, MBS, PMP

    Amgen

    Strategic Planning & Operations Manager

    Committee Member
    Moderator
    Read Bio
  • Jeff Lewis

    Jeff Lewis

    Takeda

    Director Global Manufacturing Sciences, Head of RAPID

    Presenter
    Read Bio
  • Bruce A. Loxley

    Bruce A. Loxley

    GSK

    Regulatory Inspection Compliance Director

    Presenter
    Read Bio
  • Patrick Mains

    Patrick Mains

    ValSource, Inc.

    Senior Consultant

    Presenter
    Read Bio
  • Peter J. Makowenskyj, MEng

    Peter J. Makowenskyj, MEng

    G-CON

    Director of Design Consulting

    Committee Member
    Discussion Leader
    Interest Group Leader
    Moderator
    Read Bio
  • Kate Malachowski, PhD

    Kate Malachowski, PhD

    Novavax

    Director, MS&T

    Co-Chair
    Moderator
    Read Bio
  • Fabrizio Maniglio

    Fabrizio Maniglio

    Honeywell

    Industry and Business Development Director

    Presenter
    Read Bio
  • Toni Manzano

    Toni Manzano

    Aizon

    Co-Founder and CSO

    Discussion Leader
    Interest Group Leader
    Read Bio
  • Allison Massari, MFA

    Allison Massari, MFA

    allisonmassari.com

    Burn Survivor, Patient-Advocate, and Interdisciplinary Artist

    Presenter
    Read Bio
  • Page McAndrew, PhD

    Page McAndrew, PhD

    West Pharmaceutical Services, Inc.

    Director, Scientific Communications

    Presenter
    Read Bio
  • Amanda McFarland, MS

    Amanda McFarland, MS

    ValSource, Inc.

    Senior Consultant

    Interest Group Leader
    Read Bio
  • Nathaniel Milton, PhD, RPh

    Nathaniel Milton, PhD, RPh

    Purdue University

    Professor of Practice - Industrial and Physical Pharmacy

    Trainer
    Read Bio
  • Walter Morris

    Walter Morris

    PDA

    Senior Director, Publishing

    Moderator
  • Morten Munk

    Morten Munk

    FUJIFILM Diosynth Biotechnologies

    Director, Global Alliance Management

    Interest Group Leader
    Trainer
    Read Bio
  • Ryan Murray, MS

    Ryan Murray, MS

    ValSource, Inc.

    Senior Consultant

    Committee Member
    Moderator
    Read Bio
  • Ivailo Neov

    Ivailo Neov

    Novavax

    Director, Internal Manufacturing

    Presenter
    Read Bio
  • Vivian Nguyen

    Vivian Nguyen

    QuVa Pharma

    Quality Visual Inspection Manager (Corporate)

    Presenter
    Read Bio
  • Lucia M. Novak, MSN, ANP-BC, BC-ADM

    Lucia M. Novak, MSN, ANP-BC, BC-ADM

    Diabesity, LLC

    President

    Presenter
    Read Bio
  • Colleen O'Brien, MS

    Colleen O'Brien, MS

    Gerresheimer

    Strategy and Technical Affairs

    Presenter
    Read Bio
  • Lorraine O'Shea, MS

    Lorraine O'Shea, MS

    Eli Lilly and Company

    Small Molecule and Peptide Plant Manager

    Presenter
    Read Bio
  • Ken Paddock

    Ken Paddock

    Merz Aesthetics

    Director, Global Quality Sterility Assurance

    Committee Member
    Moderator
    Read Bio
  • Malav Parikh, ME

    Malav Parikh, ME

    Takeda

    Director, Quality Risk Management, Global Quality Compliance and Systems

    Committee Member
    Interest Group Leader
    Moderator
    Read Bio
  • Divyang Patel

    Divyang Patel

    AtkinsRéalis

    Senior Consultant & Project Manager

    Committee Member
    Moderator
    Read Bio
  • Julian Petersen

    Julian Petersen

    Groninger

    Head of Business Development

    Committee Member
    Interest Group Leader
    Moderator
    Read Bio
  • William Peterson

    William Peterson

    Merck & Co., Inc.

    Director, Global QA

    Interest Group Leader
    Read Bio
  • David Phasey

    David Phasey

    3P innovation

    Projects Director

    Presenter
    Read Bio
  • Gianmarco Pincelli

    Gianmarco Pincelli

    Bonfiglioli Engineering

    Technical Sales Manager

    Presenter
    Read Bio
  • Jim N. Polarine, MA

    Jim N. Polarine, MA

    STERIS

    Principal Consultant

    Presenter
    Read Bio
  • Shelley M. Preslar, MBA

    Shelley M. Preslar, MBA

    Panacea Group

    CEO/Principal SME

    Interest Group Leader
    Read Bio
  • Sabrina Restrepo, PhD

    Sabrina Restrepo, PhD

    Merck & Co., Inc.

    Executive Director - Quality Assurance

    Interest Group Leader
    Trainer
    Read Bio
  • Lori Richter, PhD

    Lori Richter, PhD

    ALX Oncology

    Sr. Director, GxP Quality Management Systems

    Presenter
    Read Bio
  • Stephan K. Roenninger, Dr.-Ing.

    Stephan K. Roenninger, Dr.-Ing.

    Amgen

    Director Compliance, External Affairs

    Discussion Leader
    Presenter
    Read Bio
  • Josh Russell

    Josh Russell

    AST

    Vice President of Sales & Marketing

    Presenter
    Read Bio
  • Michael J. Sadowski

    Michael J. Sadowski

    Sterilexcellence

    Owner

    Trainer
    Read Bio
  • Mike Salem, MA

    Mike Salem, MA

    Gilead Sciences

    Associate Director of Data Science - Quality Assurance

    Presenter
    Read Bio
  • Sebastian Scheler, MSc

    Sebastian Scheler, MSc

    Innerspace

    Managing Director

    Presenter
    Read Bio
  • Susan J. Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Co-Chair
    Moderator
    Read Bio
  • Melissa S. Seymour, MBA

    Melissa S. Seymour, MBA

    Eli Lilly and Company

    EVP and Chief Quality Officer

    Panelist
    Presenter
    Trainer
    Read Bio
  • Ankur K. Shah, PE

    Ankur K. Shah, PE

    Arcadis

    Lead Process Engineer

    Presenter
    Read Bio
  • David Short

    David Short

    QuVa Pharma

    Chief Quality Officer

    Interest Group Leader
    Read Bio
  • Neal Siegel, PhD

    Neal Siegel, PhD

    The FDA Group

    Consultant

    Presenter
    Read Bio
  • Bethany Silva

    Bethany Silva

    Endress+Hauser

    Industry Manager - Life Sciences

    Presenter
    Read Bio
  • Michele Simone

    Michele Simone

    Bracco

    Director, Corporate Quality Compliance, Risk Management, and Continual Improvement

    Interest Group Leader
    Read Bio
  • Chiara Sinito, PhD

    Chiara Sinito, PhD

    WILCO AG

    Head of AVI

    Presenter
    Read Bio
  • Kim Sobien, MBA

    Kim Sobien, MBA

    ValSource, Inc.

    Senior Consultant - Microbiology

    Interest Group Leader
    Read Bio
  • Sebastian B Teitz, PhD

    Sebastian B Teitz, PhD

    Novo Nordisk

    Senior Development Scientist

    Committee Member
    Moderator
    Read Bio
  • Eva M. Urban, MSc

    Eva M. Urban, MSc

    Bristol Myers Squibb

    Senior Director, Risk Management

    Interest Group Leader
    Read Bio
  • Robin Usselman

    Robin Usselman

    PBL (Performing Beyond Limits)

    Sr. Business Development Manager, USA & Canada

    Committee Member
    Discussion Leader
    Moderator
    Read Bio
  • Vanessa Vasadi Figueroa, MA

    Vanessa Vasadi Figueroa, MA

    VVF Science

    Chief Microbiologist

    Committee Member
    Moderator
    Read Bio
  • Margarida Ventura, MS

    Margarida Ventura, MS

    ValGenesis

    Quality Risk Management Senior Consultant

    Presenter
    Read Bio
  • James L. Vesper, PhD, MPH

    James L. Vesper, PhD, MPH

    ValSource, Inc.

    Director, Learning Solutions

    Discussion Leader
    Read Bio
  • Kelly Waldron, PhD

    Kelly Waldron, PhD

    ValSource, Inc.

    Business Unit Manager, Quality and Manufacturing Science Consulting

    Presenter
    Read Bio
  • Anne Weeks

    Anne Weeks

    MilliporeSigma

    Senior Commercial Applications Expert

    Trainer
    Read Bio
  • Glenn E. Wright, MA

    Glenn E. Wright, MA

    PDA

    President and CEO

    Moderator
    Presenter
    Read Bio
  • Sheba S. Zaman

    Sheba S. Zaman

    Novatek

    Head of Product Specialists and Training Services

    Presenter
    Read Bio
  • Jane Zhang

    Jane Zhang

    ETCH Sourcing

    Co-Founder & Co-CEO

    Presenter
    Read Bio

Sponsors

Sponsors and Collaborators
We Thank Our 2025 Sponsors and Exhibitors

Exhibitors

Exhibitors and Innovators
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