It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations 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. 15:45 | Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, 16:05 | James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC, The following posters will be presented during each break in the Exhibit Hall. The group rate is $199 for single or double occupancy. Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Collaboration and Commitment Can Lead to Awe-Inspiring Results Interested in becoming a sponsor? Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. Website| Reservations Link. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. Rob Hall, Design Team Manager - Product Design, Owen Mumford. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. 08:30 10:00 | P3 Jake Keeler, Sr. We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. (This applies in particular to costs for submitting documents by courier.). Events | CHDI Foundation Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. 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 . Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Palm Springs International Airport (PSP) is 1.5 miles from Hotel. Important Nursing Education Conferences to Attend in 2023 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone In this session, the speakers will provide insight into state-of-the-art approaches for advancing contamination control through comprehensive analytics and trending, strategies for reduced particulate recovery, and advanced cleaning techniques using physics. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. ABRF Annual Meeting - Association of Biomolecular Resource Facilities Indulge in the ultimate relaxation at Renaissance Palm Springs Hotel. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting This session will also address the expanded scope of Annex 1 to include some non-steriles. Phone: +1 (214) 651-1234. 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. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. 13:00 | Container Closure Integrity Testing and Finishing Ontario International airport (ONT) is 70 miles from the Convention Center. Join us in Palm Springs for the ultimate educator experience! Accommodation requests must be made no later than 18 March 2022. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. : New Technology Facilitating Process-Product Communication Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. The ability to rapidly develop and manufacture mRNA vaccines with high efficacy against the SARS-CoV-2 virus is a tremendous public health accomplishment and has spurred widespread interest in mRNA vaccines for multiple infectious diseases and other indications. Bethesda, MD 20814 USA The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! 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's Universe of Pre-filled Syringes and Injection Devices Conference 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. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? After this date, reservations can be made on a space-and-rate available basis only. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). ABRF 2020, Palm Springs, California ABRF 2019, San Antonio Texas ABRF 2018, Myrtle Beach, South Carolina ABRF 2017, San Diego, California ABRF 2016, Ft. Lauderdale, Florida ABRF 2015, St. Louis, Missouri Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. Los Angeles International Airport (LAX) is 124 miles from the Convention Center. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. May 18-19, 2023. Reservations must be secured by Friday, 30 September 2022. 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 Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Moderator: Alessandro Morandotti, Head of the Technical Account Management, Stevanato Group, 13:30 | Development of New Reusable Autoinjector for Automated Reconstitution and Injection of Drug from a Disposable Dual Chamber Cartridge March 2-3, 2023. Guestroom rates are subject to State and Local taxes. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries. Tel: +65 64965504 All costs incurring in connection with visa affairs shall be borne by registrants. 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 16:40 | What If Sterile Product Processing Equipment Could Talk? Thomas James, Mechanical Engineer, Key Tech Palm Springs, CA, 400 East Tahquitz Canyon Way We will highlight what's in store for the future of pharmaceutical manufacturing. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Sbastien Cordier, Technical Product Manager, Aptar Pharma, From the Users Perspective: The Use of Eye Tracking Technology in Human Factors Studies to Assess and Improve Injection Device Usability Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. In and out privileges for hotel guests only. This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Tel: +65 64965504 Find your oasis while lounging beside one of the area's largest outdoor pools or sipping a refreshing drink in one of our private cabanas. Mark Tunkel, Global Category Director - Services, Nemera, Evaluation of Syringe Plunger Functional Performance to Secure PFS and Auto-injector Integration and Machinability on Filling Lines: Case Study with PremiumCoat 1-3mL Syringe Plunger housing law practitioners association | For those practicing housing law. Sheldon Moberg, MA, SVP Drug Delivery, Bexson Biomedical, 14:10 | A Patient-Centered Approach to Development of Novel On-Body Drug-Delivery Solutions for Injectable Biologics: A Study with Multiple Target Groups 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 Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Elizabeth Rivera, Technical Services Manager, STERIS Cancellation requests must be emailed to [emailprotected]. Ugljesa Babic, Junior Project Manager, Schott Schweiz AG. 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. Juan Cheng, Principal Scientist, Merck & Co., Inc. Copyright Parenteral Drug Association. 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). Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Alex Lyness, PhD, Senior Manager, Research and Technology, West Pharmaceutical Services, Inc. 11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. 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. October 18, 2022 - October 19, 2022. A1: Game Plan: Progress to the Next Stage of Contamination Control Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 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. Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Recent developments have shown a rising preference for self-administration of drugs, in which autoinjectors have become one of the key delivery devices supporting subcutaneous injections. 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. David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. Toni Manzano, PhD, CSO and Co-Founder, Aizon. 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 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Bethesda, MD 20814 USA Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? Interested in becoming a sponsor? We will conclude by reviewing the shared vision from a cross-industry collaboration. All rights reserved. Moderator: Marc Glogovsky, MS, S.M. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). 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. Please contact us if you are entiteld to receive a discount. John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Palm Springs, CA. The pandemic experience typified the need to be prepared for serious unanticipated events. PDA Conference October 18th-19th 2022 | Oval Medical Technologies 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions Incorporating Sustainability Considerations Within the Device Selection Process Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium Other discounts cannot be applied. Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction 2022 PDA Annex 1 Workshop (Palm Springs) Oct 20 - Oct 21, 2022 Palm Springs, CA Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The new Annex 1 revision was recently released! PDA 2022 | Cambridge Pharma Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. All rights reserved. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development B-Lot, 48 hours | $13 15:30 | Water Systems and Other Critical Utilities Palm Springs, CA Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc. 11:05 | Re-Imagine Audit: Bringing GxP Auditing into the Quality 4.0 Paradigm PDA will not be responsible for any costs incurred by registrants due to cancellation. After this date, reservations can be made on a space-and-rate available basis only. 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Learn about opportunities and benefits. IG2: Process Validation and Lyophilization. 3 to 4 p.m. Feb. 20. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Palm Springs, CA, 1300 Tahquitz Canyon Way Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. 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. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant.

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