Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Gore & Associates, Breakfast 2: Device Platforms Palm Springs Symposium on HIV/AIDS - Cancer Research Institute Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement 10:45 | Strategies for Total Contamination Control in an Aseptic Environment Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. [emailprotected], Tel: +1 (301) 656-5900 ext. Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. 10:15 | Aseptic Processing Los Angeles International Airport (LAX) is 124 miles from Hotel. HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium 15:30 | Water Systems and Other Critical Utilities Taking place in Palm Springs, CA, the Conference will dive into interactive sessions and multiple tracks that will address innovation and regulatory trends in the universe of application device technology and explore what's next for the future of this field. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 [emailprotected], Tel: +49 (0) 30 43 655 08-10 Guestroom rates are subject to State and Local taxes. Please contact us if you are entiteld to receive a discount. 15:30 16:30 | P4: Equipment, Technology, and Utilities To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. PDA Announces Nearly 100 Exhibitors at the 19th Universe of Pre-Filled Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings [emailprotected], 4350 East West Highway, Suite 600 The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Radish Lot, 48 hours | $13 Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? 277 N. Avenida Caballeros With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. 08:30 10:00 | P3 Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company. Dallas, TX The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. IG8: Facilities and Engineering GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics May 15-17, 2022. 10:15 11:20 | P6: Production Technologies, Part 1 Young Harris, GA. 13507 - Berlin, Germany Mathias Romacker, Executive Advisor,Kymanox, 11:05 | How Innovative Approaches to Subcutaneous Drug Delivery Can Shift the Point of Care from Hospital to Home: Building a Case for Oncology Continued advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization Metals and mining is in our DNA. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. Solving your drug delivery needs at PDA | Team Consulting Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems. Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Esther Foo, PhD, Senior Scientist, Merck & Co., Inc. 11:25 |Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC, 16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Palm Springs, CA Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. Bethesda, MD 20814 USA Tel: +65 64965504 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. Moderator: Manfred Maeder, Head Device Dev. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. 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. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Chuck W. Seipel, Product Specialist, W.L. This Hotel does not offer shuttle service. We will highlight whats in store for the future of pharmaceutical manufacturing. 08:00 | Day 1 Report Out Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Interested in becoming a sponsor? For your credit card information safety: Please send your details by fax only, For an easier registration, please note the helpful hints on the registration form. 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Marty Coyne, BEME, MBA, Principal, Matchstick LLC, 14:10 | Integrating Secure and Easy to Handle Connectivity into a Pre-Filled Device for Automated Injection Logging Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Individuals will be responsible for payment of their own cancellation fees. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? Cancellation requests must be emailed to [emailprotected]. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards We will highlight what's in store for the future of pharmaceutical manufacturing. By eliminating the need for silicone in both the barrel and . Moderator: Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company, 13:30 | Seven Key Pillars of Successful Connected Injection Device Development Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field. Video, photo, and audio recordings are prohibited at all PDA events. Patrick Grandt, Medical Device Engineer, Genentech, Inc. A Packaging Platform for Pre-Filled Syringes and Self-Injection Devices; How Unit-Level Compliance Can Improve Treatment Outcomes Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems. CUE 2023 will be a celebration of coming together after two years apart. This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. Individuals will be responsible for payment of their own cancellation fees. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. Rudolf Michael Weiss, Dipl.-Ing., Global Head of Pharma+Medical, Stubli, 07:35 | A Real-World Example of Sustainable Drug Delivery the Development of the First Reusable Pen Injector for Concentrated Insulin Bethesda, MD 20814 USA The biopharmaceutical industry has evolved from traditional vaccines and therapeutic proteins to encompass a broad range of modalities, including mRNAs, cell therapies, and other advanced therapeutic medicinal products. You must have this confirmation letter to be considered enrolled in a PDA event. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Herve Soukiassian, Ass. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. D1: Building Back Better: Innovative Options for Audits and Inspections 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. These emails are sent by scammers. PDA Universe of Pre-Filled Syringes and Injection Devices Conference How was it done, what were the barriers, the learnings, and how could it be done so fast? Lets discuss advances in the use of AI in automated visual inspection. Overnight Guests |$32 + tax May 18-19, 2023. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Tel: +1 (301) 656-5900, Am Borsigturm 60 Conferences in Palm Springs Category 1 filter applied Conference Clear All DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) Thu, Jun 1, 6:00 PM Private Hotel - NEW location Palm Springs, CA 57th Annual State Women's Convention James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? Valet Parking, operated by PMSI, is available at hotel entrance. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. IG5: Packaging Science B-Lot, 8-24 hours | $19 The 2022 PDA Annual Meeting promises to have something for everyone! After this date, reservations can be made on a space-and-rate available basis only. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery Weve come together to create effective tools to fight a global pandemic. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field. Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Advisor, Kymanox, 08:30 | The COVID-19 Vaccine Development Story Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. : New Technology Facilitating Process-Product Communication Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. 13:00 13:50 | P7: Production Technologies, Part 2 Bethesda, MD 20814 USA Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. Michael de la Torre, CEO, Redica Systems. If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status. With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. Rocks offers a trendy bar setting to unwind after a day of exploring the Palm Springs Aerial Tramway, Palm Springs Art Museum and boutique shops along the city's main thoroughfare. Gregg Peterson, MA, CEO, Bexson Biomedical Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. We will conclude by reviewing the shared vision from a cross-industry collaboration. Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing). Learn about opportunities and benefits. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Wendy Woodley, Staff Scientist II, BD. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Oct 12, 2022. Ypsomed is presenting a brand . Agility in development and supply chain builds on good clinical and commercial process design and realization. Palm Springs, CA, 1300 Tahquitz Canyon Way Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. The Palm Springs workshop, 20-21 Oct., is the fourth sponsored by PDA in 2022. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. With your valuable input, we can determine if there is value in having a deeper discussion (i.e., potential PDA project) around this idea of integrating, coordinating, prefabricating, or even prequalifying critical components of a facility ahead of the construction. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device If there's a child protection conference for your child Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. (NRCM), Senior Consultant Microbiology, ValSource Inc. Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. IG2: Process Validation and Lyophilization. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 Tel: +49 30 436 55 08-0 or -10 Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities. 48 hours| $26 Radish Lot, 04 hours | $9 Moderator: Theresa E. Bankston, PhD, VP Customer Success, BD, 15:45 | Digital Healthcare in Drug Delivery: The Pillars of Hardware and Software to Empower the End User This will be followed by Amgens Dr. Ronald Forster discussing the merits of developing platform technologies, and how they enable continuous improvement in the patient journey through product quality, innovation, and manufacturing efficiency. PDA Conference October 18th-19th 2022 | Oval Medical Technologies 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer The Covid-19 pandemic taught us that if from one side we need to preserve those quality and safety standards, from another we need to create an ecosystem able to react quickly to unforeseen events. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. 11:25 | Development of a Large Volume Delivery System with a Customized Injection Profile (Case Study) Phone: +1 (888) 236-2427.