October 11, 2022. 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. We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. 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. decide how to keep your child safe. The aim of this conference is to provide the latest information and to . 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Reto Jost, MSc, Innovation & Business Development Director, Ypsomed AG, 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A1: Connected Devices and Digital Ecosystems Please contact us if you are entiteld to receive a discount. No refunds will be granted for requests postmarked after April 13, 2022. Phone: +1 (214) 651-1234. Please call 214 849 6831 for bus information. 04 hours | $22 Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Other discounts cannot be applied. Join us in Palm Springs for the ultimate educator experience! Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Cancellation requests must be emailed to [emailprotected]. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). 13507 - Berlin, Germany Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. PDA's Universe of Pre-filled Syringes and Injection Devices Conference PDA will not be responsible for any costs incurred by registrants due to cancellation. Ron Pettis, Director, Translational and Clinical Sciences, BD, 15:00 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall, 15:45 17:30 | P4: Investing in the Future 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 Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? Diego Zurbriggen, Sr. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. The conference must talk about all the children in your household, even if the people there are only . Weve come together to create effective tools to fight a global pandemic. 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 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference Bethesda, MD 20814 USA The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. (This applies in particular to costs for submitting documents by courier.). Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Key learnings and best practices in partnering will be openly discussed. 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 Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. 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. After the event, Agle will sign books and the Modernism Week 2022 commemorative posters he designed, pictured above. If there's a child protection conference for your child Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 13:00 13:50 | P7: Production Technologies, Part 2 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 Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? Phone: +1 (888) 236-2427. CUE | Spring CUE 2023 Conference Oct 12, 2022. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 Palm m105 was a nice device for its time, it had a grayscale screen with a "stunning" 160x160px resolution and a 16 MHz Motorola CPU. 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. 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Michael T. Edey, Senior Principal Engineer, Pfizer Inc. 11:05 | Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium A3: Cleanroom Manufacturing: A New Area Across Technology and Processes Overnight Guests |$32 + tax Richard M Johnson, MSc, President and CEO, PDA Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA 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. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. Visit us at booth 113. These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Interested in becoming an exhibitor? PDA 2022 | Cambridge Pharma Radish Lot, 04 hours | $9 08:00 | Day 1 Report Out 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 Statements claiming to offer our attendee lists are fraudulent. Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment 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. 08:30 10:00 | P3 Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products 13507 - Berlin, Germany Tel: +1 (301) 656-5900, Am Borsigturm 60 Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Lets discuss advances in the use of AI in automated visual inspection. Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Alaska Airlines, Delta and Southwest service this airport. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. 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 Bethesda, MD 20814 USA Palm Springs Symposium on HIV/AIDS - Cancer Research Institute D1: Building Back Better: Innovative Options for Audits and Inspections Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Juan Cheng, Principal Scientist, Merck & Co., Inc. HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Please call 214 653 1101 for train information. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. 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. CUE 2023 will . The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Check-in time is 16:00; check-out time is 11:00. The 2022 PDA Annual Meeting promises to have something for everyone! 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. An Insight from PFS Manufacturing for AI A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. [emailprotected], Tel: +1 (301) 656-5900 ext. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Director Product Development PMO, BD. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Herve Soukiassian, Ass. New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company 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. Using Regulatory Grade CM&S of a Drug Delivery Systems to Accelerate Device Development Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. 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. Herve Soukiassian, Assoc. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist You must have this confirmation letter to be considered enrolled in a PDA event. Thomas James, Mechanical Engineer, Key Tech GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Palm Desert, CA. In and out privileges for overnight guests only, operated by PMSI. . Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. 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 Phone: +1 (760) 322-6100 If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. Learn about opportunities and benefits. Moderator: Manfred Maeder, Head Device Dev. All rights reserved. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations The first speaker will provide experimental results obtained from comparing both glass and polymer silicone-free container closure systems in terms of functional performance and drug stability. There is an enormous amount of data being collected today, but what does it all mean? PDA Universe of Pre-Filled Syringes and Injection Devices Conference Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S All costs incurring in connection with visa affairs shall be borne by registrants. IG3: Quality Risk Management and GXP Auditing. Self Parking 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. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. 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. This session will focus on auditing in the new normal by providing details on various techniques and technologies for effective use in audits and inspections. BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA
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