08:00 09:30 | P1: Overview of and Revision Process for Annex 1 Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Guestroom rates are subject to State and Local taxes. Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. Oct 12, 2022. Tel: +65 64965504 Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. Dr. Forster will also elaborate on how to leverage insights derived from other industries. We will highlight whats in store for the future of pharmaceutical manufacturing. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development October 18-19, 2022 Palm Springs, CA Booth #606. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Additional workshops are anticipated for 2023. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. 10:15 | Aseptic Processing Greyhound: The nearest Greyhound station is located at 205 S Lamar St. 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. Thomas James, Mechanical Engineer, Key Tech 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. The Art of Filling and Processing a Pre-filled Syringe Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. Amy Hartl, PhD, Director of Process Development, SHL Medical Rob Veasey, MSc, Senior Sector Manager, Medical & Scientific, DCA Design International, Breakfast 3: PFS Traceability: Case Studies on RFID-Based Solutions for PFSs Ypsomed is presenting a brand . Finally, we will learn about regulatory considerations. IG3: Quality Risk Management and GXP Auditing. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. 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. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. All costs incurring in connection with visa affairs shall be borne by registrants. 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. Taxi fares from DFW are approximately $45-50 one way, not including tip. [emailprotected], 4350 East West Highway, Suite 600 Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. 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. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. Taxi fares from DAL are approximately $20-25 one way, not including tip. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . 04 hours | $22 Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. Xi Zhao, Senior Scientist, Merck & Co., Inc. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. Copyright Parenteral Drug Association. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. Valet Parking, operated by PMSI, is available at hotel entrance. Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. Palm Springs Convention Center. Phone: +1 (760) 322-6100 Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). 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. Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. 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. Paul Erik Fabricius, Director, Front End Innovation, Phillips-Medisize, 13:50 | Integrating Novel Drug Formulation and Wearable Pump Technologies to Deliver Non-Opioid Moderate to Severe Pain Management Outside of the Clinic 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. The group rate is $199 for single or double occupancy. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply Moderator: Marc Glogovsky, MS, S.M. Ulrich Kllisch, PhD, Manager Data Integrity, GxP-CC, 11:05 | A Deep Dive into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights All rights reserved. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement Estimated Taxi Fare 7 USD (one way). Bethesda, MD 20814 USA The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. 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. PDA will not be responsible for any costs incurred by registrants due to cancellation. [emailprotected], Tel: +49 (0) 30 43 655 08-10
11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Collaboration and Commitment Can Lead to Awe-Inspiring Results 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 277 N. Avenida Caballeros
All costs incurring in connection with visa affairs shall be borne by registrants. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. 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 Max Fill Volume Evaluation for Pre-filled Syringes This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). This airport is serviced by numerous carriers. 13507 - Berlin, Germany PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Interested in becoming an exhibitor? Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) March 2-3, 2023. Valet Parking 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 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. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions Individuals will be responsible for payment of their own cancellation fees. The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. Aboda Marching Band Results,
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