pda conference 2022 palm springs

Tel: +1 (301) 656-5900, Am Borsigturm 60 It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 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 3 people interested. IG1: Biopharmaceutical Manufacturing Radish Lot, 04 hours | $9 Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Please contact us if you are entiteld to receive a discount. Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Moderator: Alessandro Morandotti, Head of the Technical Account Management, Stevanato Group, 13:30 | Development of New Reusable Autoinjector for Automated Reconstitution and Injection of Drug from a Disposable Dual Chamber Cartridge Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger In this session, speakers will share best practices for container integrity important for vaccine distribution and quality by design principles applied in viral product development. Dallas, TX Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors CUE 2023 will . Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? Palm Springs, CA D3:Data Integrity Trends, Patterns, and Insights You must have this confirmation letter to be considered enrolled in a PDA event. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. 13:00 14:15 | P3: Premises and Barrier Systems Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia [emailprotected], Tel: +49 (0) 30 43 655 08-10 October 11, 2022. Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Los Angeles International Airport (LAX) is 124 miles from the Convention Center. The 2022 PDA Annex 1 Workshops highlight critical changes in the new regulation and include interactive sessions to provide attendees with a clear understanding of and means to implement all the requirements of the rule. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. 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. An Insight from PFS Manufacturing for AI Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. 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 Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. 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 All costs incurring in connection with visa affairs shall be borne by registrants. Toni Manzano, PhD, CSO and Co-Founder, Aizon. 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). Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. B2: New Technologies in Bioprocessing Alaska Airlines, Delta and Southwest service this airport. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand 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. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. This conference gives Georgia-based nursing educators an opportunity to come together and learn about issues and trends related to nursing education in their state. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! 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 This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing together industry experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends in this exciting area. 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 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. 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 Art of Filling and Processing a Pre-filled Syringe 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. By eliminating the need for silicone in both the barrel and . You must have this confirmation letter to be considered enrolled in a PDA event. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Video, photo, and audio recordings are prohibited at all PDA events. Amy Hartl, PhD, Director of Process Development, SHL Medical The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Bethesda, MD 20814 USA The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. 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 Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Mark Tunkel, Global Category Director - Services, Nemera, Evaluation of Syringe Plunger Functional Performance to Secure PFS and Auto-injector Integration and Machinability on Filling Lines: Case Study with PremiumCoat 1-3mL Syringe Plunger Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting This opening plenary features keynotes from two senior biopharmaceutical leaders. Moderator: Mathias Romacker, Executive Advisor,Kymanox. Check-in time is 16:00; check-out time is 11:00. IG6: Microbiology/ Environmental Monitoring The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Learn about opportunities and benefits. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. DP and Critical Materials, Bristol-Myers Squibb. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. Interested in becoming an exhibitor? Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development Mathias Romacker, Executive Advisor,Kymanox, 11:05 | How Innovative Approaches to Subcutaneous Drug Delivery Can Shift the Point of Care from Hospital to Home: Building a Case for Oncology For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Humberto Vega, PhD, Sr. Director - Ext. 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. Palm Springs, CA, 1300 Tahquitz Canyon Way In and out privileges for overnight guests only, operated by PMSI. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Individuals will be responsible for payment of their own cancellation fees. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond 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 Ypsomed is presenting a brand . To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. 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. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies Metals and mining is in our DNA. Reservations must be secured by Friday, 04 March 2022. 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. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. In this session, the speakers will provide insight into state-of-the-art approaches for advancing contamination control through comprehensive analytics and trending, strategies for reduced particulate recovery, and advanced cleaning techniques using physics. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. 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. 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 Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Chuck W. Seipel, Product Specialist, W.L. The new Annex 1 revision was recently released! 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering 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. Valet Parking, operated by PMSI, is available at hotel entrance. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. 3 to 4 p.m. Feb. 20. 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. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Tel: +1 (301) 656-5900, Am Borsigturm 60 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 Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. A Novel Device for Reconstitution and Administration Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA For more details visit the concerence website . The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. Please contact us if you are entiteld to receive a discount. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience.

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