This session will expand on the regulatory challenges we have endured and how we anticipate the future. Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment 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). PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Weve come together to create effective tools to fight a global pandemic. Statements claiming to offer our attendee lists are fraudulent. Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. 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 Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. 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. Phone: +1 (760) 322-6100 The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist The aim of this conference is to provide the latest information and to . 13:00 13:50 | P7: Production Technologies, Part 2 The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. PDA Conference 2022 | Recipharm 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 Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. Check-in time is 16:00; check-out time is 11:00. Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. The conference must talk about all the children in your household, even if the people there are only . Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. decide if a child protection plan should be drawn up for your child. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Esther Foo, PhD, Senior Scientist, Merck & Co., Inc. 11:25 |Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products Consider the possibilities: Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. Tel: +1 (301) 656-5900, Am Borsigturm 60 Juan Cheng, Principal Scientist, Merck & Co., Inc. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Chuck W. Seipel, Product Specialist, W.L. Dallas, TX 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. Website| Reservations Link. 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 Los Angeles International Airport (LAX) is 124 miles from the Convention Center. 04 hours | $22 Mark Zimmerman, MBA, Business Development, Kimball Electronics, How to Study and Characterize the Container Closure Integrity of Glass Prefilled Syringes During Deep-Cold Storage Cycles Discuss market, industry trends and new technologies. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes 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. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment. 888 Tahquitz Canyon Way It's time to come together and celebrate all that is good about being an educator. October 18, 2022 - October 19, 2022. In this session, the speakers will provide insight into modern microbial methods by discussing the validation process and regulatory acceptance for an automated colony counter utilizing a cross functional industry team, navigating speedbumps throughout implementation of a biofluorescent particle counting system, and a case study on rapid microbial detection for a purified water system. 277 N. Avenida Caballeros : New Technology Facilitating Process-Product Communication If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals 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. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC, 16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing No credits will be given for cancellation requests received less than 30 days before the event. 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. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Learn about opportunities and benefits. The pandemic experience typified the need to be prepared for serious unanticipated events. Estimated Taxi Fare 7 USD (one way). Fax: +65 6496 5599, Manager Registration, Chapters & Membership. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? Rob Veasey, MSc, Senior Sector Manager, Medical & Scientific, DCA Design International, Breakfast 3: PFS Traceability: Case Studies on RFID-Based Solutions for PFSs If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 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. The new Annex 1 revision was recently released! The group rate at all hotels is $199 for single or double occupancy. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. May 18-19, 2023. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. 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. 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 This Hotel does not offer shuttle service. We will highlight whats in store for the future of pharmaceutical manufacturing. Accommodation requests must be made no later than 18 March 2022. 15:00 | Environmental and Process Monitoring 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID 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 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 In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Radish Lot, 8-24 hours | $19 This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. Reut Atarot, Systems Engineering Manager, West Pharmaceutical Services, Inc. 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A4: Patient-Driven Collaborations and New Delivery Technologies Oct 12, 2022. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing). 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. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics B2: New Technologies in Bioprocessing What if formulations could be synthesized when and where they are needed? 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. Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Marty Coyne, BEME, MBA, Principal, Matchstick LLC, 14:10 | Integrating Secure and Easy to Handle Connectivity into a Pre-Filled Device for Automated Injection Logging Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). 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 PDA Announces Nearly 100 Exhibitors at the 19th Universe of Pre-Filled Elizabeth Rivera, Technical Services Manager, STERIS Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group Get in touch with Aenova and contact us here ! 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. 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. Herve Soukiassian, Assoc. Important Nursing Education Conferences to Attend in 2023 3 people interested. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. Lee Leichter, RAC, MBA, President, P/L Biomedical. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. D1: Building Back Better: Innovative Options for Audits and Inspections 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. 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. 2022 Annual Meeting and Workshops Registration | Society of 2022 PDA Annex 1 Workshop (Palm Springs) Oct 20 - Oct 21, 2022 Palm Springs, CA Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The new Annex 1 revision was recently released! Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Please contact us if you are entiteld to receive a discount. Palm Springs Symposium on HIV/AIDS - Cancer Research Institute 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 workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices Learn about opportunities and benefits. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) 13:00 | Container Closure Integrity Testing and Finishing A1: Game Plan: Progress to the Next Stage of Contamination Control 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. 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 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. She will verify your status and register you. 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 Other discounts cannot be applied. David Booth, PE, Senior Consultant, LMI. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. IG1: Biopharmaceutical Manufacturing Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. 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. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success Individuals will be responsible for payment of their own cancellation fees. Moderator: Manfred Maeder, Head Device Dev. Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event. John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. 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. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Palm Springs, CA Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company Visit us at booth 113. 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 balance would give the pharmaceutical industry the ability to positively impact patients by offering new treatments faster.
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