D1: Building Back Better: Innovative Options for Audits and Inspections Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. (This applies in particular to costs for submitting documents by courier.). Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings Stefan R. Kappeler, PhD, Senior Director Biopharma and Regulatory, Exyte Central Europe GmbH, 11:25 | Quality by Design for Adeno-Associated Virus Products: A Framework It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 CG Global Metals & Mining Conference - Canaccord Genuity C3: Responding to Patient Needs Marc Glogovsky, MS, S.M. Tel: +49 30 436 55 08-0 or -10 Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals Parking at the Convention Center costs $10 daily. John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. PDA Conference October 18th-19th 2022 | Oval Medical Technologies PDA Universe of Pre-Filled Syringes and Injection Devices Conference The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Palm Springs International Airport (PSP) is 1.5 miles from Hotel. 08:00 | Day 1 Report Out Palm Springs Symposium on HIV/AIDS - Cancer Research Institute PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. Valet Parking Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. Amin Sedighiamiri, PhD, Associate Director, AstraZeneca, 13:50 | Addressing Primary Container Challenges in Autoinjector Drug Delivery: Interim Results of a Multiphase Bioburden Study for a Cartridge-Based Autoinjector Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning The revised Annex 1 contains a significant amount of new and more detailed content on many topics. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. Rob Veasey, MSc, Senior Sector Manager, Medical & Scientific, DCA Design International, Breakfast 3: PFS Traceability: Case Studies on RFID-Based Solutions for PFSs 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. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA PDA Conference October 18th-19th 2022. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). Alaska Airlines, Delta and Southwest service this airport. Video, photo, and audio recordings are prohibited at all PDA events. 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. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. She will verify your status and register you. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. By eliminating the need for silicone in both the barrel and . IG2: Process Validation and Lyophilization. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Subsequently, we will focus on best practices to validate the method using multivariate approach. No credits will be given for cancellation requests received less than 30 days before the event. Moderator: Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company, 13:30 | Seven Key Pillars of Successful Connected Injection Device Development Joerg Stumbaum, Project Manager, PPS&P, Vetter ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) 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. Through the understanding of this data, and what it means, our industry can improve its compliance position and continuously improve to produce safe and effective medicine for patients. Bethesda, MD 20814 USA Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. 04 hours | $22 Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG In this Interest Group Meeting, participants will discuss PDA Technical Report No. Bethesda, MD 20814 USA 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. Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. Bethesda, MD 20814 USA Accommodation requests must be made no later than 18 March 2022. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). 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. You can't miss the closing session "Investing in the Future," featuring Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, and James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC. Tel: +65 64965504 Philip A. Villari, MS, Associate Principal Scientist, Merck & Co., Inc. 11:25 | A Rapid Microbial Detection Technology to Identify Water Purification Failures in Real Time 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. IG5: Packaging Science Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. All rights reserved. David Booth, PE, Senior Consultant, LMI. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Other discounts cannot be applied. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. 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. Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. Xi Zhao, Senior Scientist, Merck & Co., Inc. Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices 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 Metals and mining is in our DNA. Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems What if formulations could be synthesized when and where they are needed? James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 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. Palm Springs, CA Conferences | Eventbrite Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Richard M Johnson, MSc, President and CEO, PDA This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. Palm Springs Convention Center. Solving your drug delivery needs at PDA | Team Consulting If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector This session will discuss the latest developments in industry standardization. (This applies in particular to costs for submitting documents by courier.). PDA Universe of Pre-Filled Syringes and Injection Devices Conference Open letter to the Secretaries of State for Housing and Justice - 10/10/2022. housing law practitioners association | For those practicing housing law. The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Finally, we will learn about regulatory considerations. Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Tel: +1 (301) 656-5900, Am Borsigturm 60 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. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. 16:40 | What If Sterile Product Processing Equipment Could Talk? Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Oct 12, 2022. [emailprotected], Tel: +49 (0) 30 43 655 08-10
Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. IG1: Biopharmaceutical Manufacturing Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration The Beneficial Feedback Loop of the Digital Twin Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch Alex Lyness, PhD, Senior Manager, Research and Technology, West Pharmaceutical Services, Inc. 11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement The agenda is available! Top PFAS Conferences in 2022 | News Direct For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022. Check-in time is 16:00; check-out time is 11:00. All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. Consider the possibilities: This Hotel does not offer shuttle service. 824 hours | $32. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply Learn about opportunities and benefits. This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. Gregg Peterson, MA, CEO, Bexson Biomedical Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond All costs incurring in connection with visa affairs shall be borne by registrants. Other discounts cannot be applied. IG8: Facilities and Engineering 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. 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. 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 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. October 18, 2022 - October 19, 2022. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. 13507 - Berlin, Germany An Insight from PFS Manufacturing for AI Director Product Development PMO, BD. Learn about opportunities and benefits. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. 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. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. 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. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Advisor, Kymanox, 08:30 | The COVID-19 Vaccine Development Story Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group), Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter, 10:45 | Primary Container Sequence for On-body Large Volume Injectors: From Vial to Pre-filled Cartridge Other vaccine platforms and manufacturing technologies that have received less attention will also be important in the future to produce vaccines that can be rapidly manufactured at a low cost, with characteristics needed for easy storage and distribution. Characterizations of Plunger Stopper Movement Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process. Interested in becoming a sponsor? Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability