Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System B-Lot, 8-24 hours | $19 Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 May 15-17, 2022. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. Join us for our global Metals and Mining conference bringing together . Maggie Reiff, Vice President, Development, ApiJect Corp. At the completion of this conference, attendees will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Learn about opportunities and benefits. 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. Palm Springs, CA Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. 13507 - Berlin, Germany This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. Get in touch with Aenova and contact us here ! 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH, C2: Transforming Product and Process Knowledge Acquisition to Become More Agile Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. May 18-19, 2023. 2022 PDA Annex 1 Workshop: Palm Springs Oct 20 - Oct 21, 2022 Frederic B. Ayers 2022 annex 1 palm springs presenter Eli Lilly and Company Fred was a student-athlete at Franklin College of Indiana and participated in the college's Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. Naresh K. Budhavaram, PhD, Senior Consultant Engineer, Eli Lilly and Company, 16:05 | Assessing the Environmental Impact of Global Supply Chain Logistics and Supplier Selection for Injection Devices Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. 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). Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach We will highlight what's in store for the future of pharmaceutical manufacturing. 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. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Gore & Associates, Breakfast 2: Device Platforms 15:30 16:30 | P4: Equipment, Technology, and Utilities Individuals will be responsible for payment of their own cancellation fees. A1: Game Plan: Progress to the Next Stage of Contamination Control Ontario International airport (ONT) is 70 miles from Hotel. Michael de la Torre, CEO, Redica Systems. What if formulations could be synthesized when and where they are needed? 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. 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. James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator Copyright Parenteral Drug Association. Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG, 07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components IG2: Process Validation and Lyophilization. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems. Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. The focus of this Interest Group will be to discuss different approaches and methodologies to increase our ability to cut down the time it takes to get to market. Agle will also host a print release party with . 13507 - Berlin, Germany PDA will not be responsible for any costs incurred by registrants due to cancellation. CUE 2023 will be a celebration of coming together after two years apart. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. 48 hours| $26 Cancellation requests must be emailed to [emailprotected]. 115 Taxi fares from DFW are approximately $45-50 one way, not including tip. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings 300 Reunion Boulevard 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. 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. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! October 18-19, 2022 Palm Springs, CA Booth #606. 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. Rob Hall, Design Team Manager - Product Design, Owen Mumford. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. [emailprotected], Tel: +1 (301) 656-5900 ext. Thomas James, Mechanical Engineer, Key Tech After this date, reservations can be made on a space-and-rate available basis only. Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Patrick Poisson,EVP, Technical Operations, United Therapeutics Corp. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization). Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 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. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes. Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems In this cant-miss closing session, Don Jones and Jim Collins will provide insight into how the drug delivery, device, and connected care market is evolving, and how the key trends might be evaluated for investment by delivery device and biopharmaceutical companies. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. 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. This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning 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. Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist 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. 08:00 | Day 1 Report Out Taxi fares from DAL are approximately $20-25 one way, not including tip. Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies Discuss market, industry trends and new technologies. Leader: Susan M. Dounce, PhD, Director Commercial Technology Development, West Pharmaceutical Services, Inc. We will highlight whats in store for the future of pharmaceutical manufacturing. After this date, reservations can be made on a space-and-rate available basis only. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces Chuck W. Seipel, Product Specialist, W.L. 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference Oct 18 - Oct 19, 2022 Palm Springs, CA The New Normal in Injectable Drug Delivery Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The agenda is available! Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S : New Technology Facilitating Process-Product Communication Bethesda, MD 20814 USA Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. As the development and production of vaccines need to be prepared for the future, participants will also learn how this can be achieved through implementing end-to-end digitization. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Join us in Palm Springs for the ultimate educator experience! This session will explore various opportunities for making home drug delivery a reality from smart delivery devices for the home setting, enabling primary containers for single use administration to patient training and on-boarding solutions specifically designed for at-home use. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Steven R. Kaufman, MBA, Vice President, Drug Delivery Systems, Stevanato Group, 11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study 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 Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. Amanda M. McFarland, BS, Senior Consultant, ValSource Inc. 10:20 | Aseptic Process Simulations The New Normal in Injectable Drug Delivery. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. There is an enormous amount of data being collected today, but what does it all mean? 18/10/2022 - 19/10/2022 Palm Springs, CA. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? Guestroom rates are subject to State and Local taxes. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Mfg. The group rate at all hotels is $199 for single or double occupancy. Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 This airport is serviced by numerous carriers. Cancellation requests must be emailed to [emailprotected]. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. $18. 13:00 | Container Closure Integrity Testing and Finishing Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. With a proven track record of success, our global and diverse team understands the importance of an international, coordinated approach in this highly specialized sector. Visit us at booth 113. She will verify your status and register you. For more details visit the concerence website . 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions The agenda is available! Reservations must be secured by Friday, 04 March 2022. Radish Lot, 48 hours | $13 Drug-Device Combination Products (DDCP) Development and Lifecycle Planning 3 people interested. and Commercialization, Device Dev/Commercialization, Novartis International AG, 13:30 | Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Product Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals 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. 16:40 | What If Sterile Product Processing Equipment Could Talk? In and out privileges for hotel guests only. In this session, speakers will share best practices for container integrity important for vaccine distribution and quality by design principles applied in viral product development. Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 888 Tahquitz Canyon Way 13:00 13:50 | P7: Production Technologies, Part 2 (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event. No refunds will be granted for requests postmarked after April 13, 2022. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products oklahoma state wrestling record, linden, nj police department non emergency number, clam digging in tampa bay,
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