The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. After this date, reservations can be made on a space-and-rate available basis only. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in 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. BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA IG3: Quality Risk Management and GXP Auditing. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Los Angeles International Airport (LAX) is 124 miles from Hotel. Type: In-personWhen: May 22-26, 2022Where: Palm Springs, California Conference overview: Battelle's 2022 conference for environmental professionals will cover a range of topics including: Dedicated presentations on PFAS issues Innovations and technologies to address chlorinated and recalcitrant compounds in the environment Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group 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 Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals She will verify your status and register you. A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. 10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group 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). Copyright Parenteral Drug Association. Interested in becoming an exhibitor? Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 15:45 | Hybrid Prefilled Syringes Suitable for Cold Storage Vaccines and Biologic Drugs Without Compromising Container Closure Integrity 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 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 Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy. Please contact us if you are entiteld to receive a discount. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. In this session, attendees will hear insights and analyses from three experts who have reviewed industry data trends in the areas of data integrity, regulatory observations, and recalls. Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. In January 2020, the first U.S. case of COVID-19 was confirmed, declared a pandemic in March, and by April, nearly half of the world's population was under lockdown. 04 hours | $22 10:45 | Data Integrity Trends in 2021 In and out privileges for hotel guests only. Finally, we will discuss where commonalities exist between antibody therapies and advanced therapies which would allow the substantial packaging knowledge amassed to date to be translated and leveraged in this rapidly changing landscape. 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. Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics Fax: +65 6496 5599, Manager Registration, Chapters & Membership. [emailprotected], 4350 East West Highway, Suite 600 Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices This session will also address the expanded scope of Annex 1 to include some non-steriles. David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs decide how to keep your child safe. Interested in becoming a sponsor? 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System In this Interest Group Meeting, participants will discuss PDA Technical Report No. 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. Interested in becoming a sponsor? 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. October 11, 2022. On-site Parking is 35 USD daily. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities All rights reserved. Video, photo, and audio recordings are prohibited at all PDA events. The 2022 PDA Annual Meeting promises to have something for everyone! Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Estimated Taxi Fare 7 USD (one way). HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply Palm Springs, CA, 1300 Tahquitz Canyon Way Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. 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. Thomas James, Mechanical Engineer, Key Tech Drug-Device Combination Products (DDCP) Development and Lifecycle Planning 2022 edition of PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be held at Palm Springs Convention Center, Palm Springs starting on 18th October. Compared to it, Palm TX looks much better it was . 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 Video, photo, and audio recordings are prohibited at all PDA events. Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 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 Gregg Peterson, MA, CEO, Bexson Biomedical Join us in Palm Springs for the ultimate educator experience! Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Peter Holst, Co-Founder and CEO, FPrin, LLC. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery 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. 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. 13507 - Berlin, Germany May 15-17, 2022. Learn about opportunities and benefits. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. The agenda is available! 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. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Amanda M. McFarland, BS, Senior Consultant, ValSource Inc. 10:20 | Aseptic Process Simulations 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 Keep an eye out for John Burke, Chris Hurlstone, Alastair Willoughby and Andy Fry to find out how Team Consulting could support your next parenteral device development. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 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. Characterizations of Plunger Stopper Movement Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. 115 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. DP and Critical Materials, Bristol-Myers Squibb. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be live in Palm Springs from the 18th-19th October and we're looking forward to seeing you there. 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: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. [emailprotected], Tel: +49 (0) 30 43 655 08-10 You must have this confirmation letter to be considered enrolled in a PDA event. The conference must talk about all the children in your household, even if the people there are only . This opening plenary features keynotes from two senior biopharmaceutical leaders. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Interested in becoming a sponsor? B2: New Technologies in Bioprocessing 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. Learn about opportunities and benefits. CG Global Metals & Mining Conference. [emailprotected], Tel: +49 (0) 30 43 655 08-10 D3:Data Integrity Trends, Patterns, and Insights All rights reserved. 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. 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 Bethesda, MD 20814 USA Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. Collaboration and Commitment Can Lead to Awe-Inspiring Results Reservations must be secured by Friday, 04 March 2022. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning 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. Richard M Johnson, MSc, President and CEO, PDA Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. 115 Ypsomed is presenting a brand . The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Tel: +1 (301) 656-5900 Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. After this date, reservations can be made on a space-and-rate available basis only. The 2022 PDA Annual Meeting promises to have something for everyone! Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Copyright Parenteral Drug Association. You must have this confirmation letter to be considered enrolled in a PDA event. 15:30 16:30 | P4: Equipment, Technology, and Utilities The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Agle will also host a print release party with . It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 08:00 | Day 1 Report Out Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Alex Lyness, PhD, Senior Manager, Research and Technology, West Pharmaceutical Services, Inc. 11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. Interested in becoming an exhibitor? 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 have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. What if formulations could be synthesized when and where they are needed? 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 Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Join us for our global Metals and Mining conference bringing together . If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. 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. This session opens our in-depth look at the content of the draft Annex 1. 10:15 11:20 | P6: Production Technologies, Part 1 Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic She will verify your status and register you. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development Amy Hartl, PhD, Director of Process Development, SHL Medical Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors Yashvinder Sabharwal, PhD, Chief Executive Officer, CherryCircle Software, Inc. 16:20 | The Digital Gap in the Pharma Industry: Effects in Patients and the Recipe to Succeed in the Journey PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company.
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