(NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Cancellation requests must be emailed to [emailprotected]. To make reservations, individuals should click on the reservation link above. Stefano Pilati, Technical Evaluation and Product Development Coordinator, Stevanato Group, How to Leverage Your Device Supply Chain and Bring Unique Combination Products and Medical Devices to Market Quicker You must have this confirmation letter to be considered enrolled in a PDA event. Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Oct 12, 2022. 10:15 11:20 | P6: Production Technologies, Part 1 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering Tel: +1 (301) 656-5900 Interested in becoming a sponsor? Characterizations of Plunger Stopper Movement Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. 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. Tel: +49 30 436 55 08-0 or -10 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. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 2022 PDA Annex 1 Workshop Palm Springs | Speakers 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. ABRF Annual Meeting - Association of Biomolecular Resource Facilities 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. Top PFAS Conferences in 2022 | News Direct In and out privileges for overnight guests only, operated by PMSI. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices 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 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. At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. Lynne Liao, Senior Engineer I, Alexion Pharmaceuticals, 13:50 | Advancements in Fully Robotic No-Touch-Transfer Solutions Used to Introduce RTU Containers into Aseptic Isolators, Enhancing Contamination Control and Sterility Assurance Please call 214 653 1101 for train information. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. D1: Building Back Better: Innovative Options for Audits and Inspections Finally, we will learn about regulatory considerations. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Radish Lot, 04 hours | $9 Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics Individuals will be responsible for payment of their own cancellation fees. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). All costs incurring in connection with visa affairs shall be borne by registrants. Tel: +1 (301) 656-5900, Am Borsigturm 60 . With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! Tom Mayer, MBA, Business Unit Manager, Sonceboz SA IG5: Packaging Science Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins March 2-3, 2023. Important Nursing Education Conferences to Attend in 2023 Guestroom rates are subject to State and Local taxes. Bethesda, MD 20814 USA After this date, reservations can be made on a space-and-rate available basis only. Parking at the Convention Center costs $10 daily. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. 08:30 | The Challenges and Rewards Developing a World-Changing Pharmaceutical Innovative and Disrupted Patient-Focused Solution 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference 3 to 4 p.m. Feb. 20. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 824 hours | $32. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. The rate is $249 for single or double occupancy. 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. Copyright Parenteral Drug Association. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. 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. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Moderator: Marc Glogovsky, MS, S.M. Moderator: Mathias Romacker, Executive Advisor,Kymanox. Jason J. Orloff, ChE, Principal Engineer and Statistician, PharmStat, 11:25 | Continuous Bioprocessing: Regulatory Harmonization and Industry Best Practices Quality and Regulatory Shifts Driving Implementation of Flexible Biopharmaceutical Manufacturing Systems Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. Tel: +65 64965504 To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Statements claiming to offer our attendee lists are fraudulent. This session opens our in-depth look at the content of the draft Annex 1. 2022 Annual Meeting and Workshops Registration | Society of Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 CG Global Metals & Mining Conference - Canaccord Genuity If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. decide if a child protection plan should be drawn up for your child. Phone: +1 (888) 236-2427. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. 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. Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 09:00 | Q&A with Additional Panelist She will verify your status and register you. Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? [emailprotected], 4350 East West Highway, Suite 600 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R Marc Glogovsky, MS, S.M. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . Copyright Parenteral Drug Association. 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 Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. 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.This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. This Conference will focus on the theme to Level Up: Agility in the New Normal! [emailprotected], Tel: +1 (301) 656-5900 ext. 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
Beautifully Done In A Sentence,
Ark Official Trading Discord Pc,
Recent Fatal Car Accidents Michigan 2021,
Qantas Entertainment November,
Articles P
