pda conference 2022 palm springs

HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Moderator: Mathias Romacker, Executive Advisor,Kymanox. The trend to move therapies to the home setting has been known for some time but the pandemic has accelerated and changed drug formulation strategies. Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics Taxi fares from DFW are approximately $45-50 one way, not including tip. Reservations must be secured by Friday, 04 March 2022. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. After this date, reservations can be made on a space-and-rate available basis only. 15:30 | Water Systems and Other Critical Utilities C3: Responding to Patient Needs IG6: Microbiology/ Environmental Monitoring Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. Rob Veasey, MSc, Senior Sector Manager, Medical & Scientific, DCA Design International, Breakfast 3: PFS Traceability: Case Studies on RFID-Based Solutions for PFSs PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole. [emailprotected], Tel: +49 (0) 30 43 655 08-10 John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Statements claiming to offer our attendee lists are fraudulent. To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. PDA will not be responsible for any costs incurred by registrants due to cancellation. 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes This session will provide insight on critical design principles during the development of a (large volume) autoinjector, including real-time assessments to share important learnings from industry leaders. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing Reservations must be secured byFriday, 23 September 2022. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study Tel: +1 (301) 656-5900 Please call 214 653 1101 for train information. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance PDA 2022 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. 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. The New Normal in Injectable Drug Delivery. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. This is the final workshop in a series that PDA has hosted in 2022 to educate and help the industry implement the new Annex 1 revision. 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 The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Tel: +49 30 436 55 08-0 or -10 Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Important Nursing Education Conferences to Attend in 2023 Palm Springs, CA, 400 East Tahquitz Canyon Way Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? For later registrations, PDA Europe will be unable to assist participants in any visa affairs. D3:Data Integrity Trends, Patterns, and Insights Dr. Forster will also elaborate on how to leverage insights derived from other industries. 13:55 | Donna Boyce, MS, Senior Vice President Global Regulatory Affairs, Pfizer Inc. 15:30 17:00 | 15:30 17:00 | P2: Facing the Future Top PFAS Conferences in 2022 | News Direct Michael de la Torre, CEO, Redica Systems. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia 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 Wendy Woodley, Staff Scientist II, BD. 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 Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? 13507 - Berlin, Germany 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. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. 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. Mark Zimmerman, MBA, Business Development, Kimball Electronics, How to Study and Characterize the Container Closure Integrity of Glass Prefilled Syringes During Deep-Cold Storage Cycles Chuck W. Seipel, Product Specialist, W.L. 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. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. William G. Whitford, Life Science Strategic Solutions Leader, DPS Group, 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? Join us in Palm Springs for the ultimate educator experience! There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Gore & Associates, Breakfast 2: Device Platforms 15:30 16:30 | P4: Equipment, Technology, and Utilities What if formulations could be synthesized when and where they are needed? GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 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. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. Finally, we will learn about regulatory considerations. A3: Cleanroom Manufacturing: A New Area Across Technology and Processes 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. 824 hours | $32. The Art of Filling and Processing a Pre-filled Syringe 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. Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning 08:00 | Welcome Remarks from Workshop Co-Chair Palm Springs, CA PDA will not be responsible for any costs incurred by registrants due to cancellation. Amy Hartl, PhD, Director of Process Development, SHL Medical 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. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). We will conclude by reviewing the shared vision from a cross-industry collaboration. 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. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 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 This session will present impressive opportunities for the future, such as having pharmaceutical products available on demand, and a vision of potential outcomes if companies can move past the concept of wanting to be a fast second to adopting new technologies moving towards a future of going first together! Connecting People, Science and Regulation, Gov./Health Authority/Academic (Member/Non-Member), Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision, Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Self Parking Discuss the market benefits of pre-filled syringes and injection devices; Identify critical attributes of end-user friendly devices; Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime; Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices, and final drug/device combo products; Discuss quality standards, regulatory and compliance concerns; List insights through case studies presented by industry experts; and.
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