Phone: +1 (214) 651-1234. Other discounts cannot be applied. Taxi fares from DFW are approximately $45-50 one way, not including tip. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. Join us in Palm Springs for the ultimate educator experience! Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain Humberto Vega, PhD, Sr. Director - Ext. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability Lee Leichter, RAC, MBA, President, P/L Biomedical. Wendy Woodley, Staff Scientist II, BD. Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R May 15-17, 2022. The session will include a discussion on the key opportunities and challenges ahead, as well as how biopharma representatives should evaluate investment options in this future changing market. Self Parking Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. 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 If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. App based rides are available to/from the airport. Tel: +1 (301) 656-5900, Am Borsigturm 60 Overnight Guests |$32 + tax Bethesda, MD 20814 USA Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement 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. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery $18. 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 Moderator: Manfred Maeder, Head Device Dev. After the event, Agle will sign books and the Modernism Week 2022 commemorative posters he designed, pictured above. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development 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. Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. 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 Director Product Development PMO, BD. The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Gore & Associates, Breakfast 2: Device Platforms Gregg Peterson, MA, CEO, Bexson Biomedical Tel: +65 64965504 Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. Additional workshops are anticipated for 2023. Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Palm Springs International Airport (PSP) is 1.5 miles from Hotel. May 18-19, 2023. 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. 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. 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. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. Other discounts cannot be applied. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices 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). Tel: +1 (301) 656-5900 She will verify your status and register you. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 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. 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Recent developments have shown a rising preference for self-administration of drugs, in which autoinjectors have become one of the key delivery devices supporting subcutaneous injections. We will highlight what's in store for the future of pharmaceutical manufacturing. B-Lot, 04 | $7 Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. . Individuals will be responsible for payment of their own cancellation fees. Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations 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 Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Parking at the Convention Center costs $10 daily. Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. [emailprotected], 4350 East West Highway, Suite 600 Reto Jost, MSc, Innovation & Business Development Director, Ypsomed AG, 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A1: Connected Devices and Digital Ecosystems The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? The purpose of a child protection conference is to: share information between all the professionals who are working with your family. 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. Herve Soukiassian, Assoc. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity Guestroom rates are subject to State and Local taxes. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 09:00 | Q&A with Additional Panelist Type: In-personWhen: May 22-26, 2022Where: Palm Springs, California Conference overview: Battelle's 2022 conference for environmental professionals will cover a range of topics including: Dedicated presentations on PFAS issues Innovations and technologies to address chlorinated and recalcitrant compounds in the environment [emailprotected], Tel: +1 (301) 656-5900 ext. Cancellation requests must be emailed to [emailprotected]. Juan Cheng, Principal Scientist, Merck & Co., Inc. 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. 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. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy. Moderator: Marc Glogovsky, MS, S.M. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms DP and Critical Materials, Bristol-Myers Squibb. 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 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 Regulatory requirements, industry experience, and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes or other pre-filled containers and injection devices to drug delivery. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies The revised Annex 1 contains a significant amount of new and more detailed content on many topics. Weve come together to create effective tools to fight a global pandemic. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA You must have this confirmation letter to be considered enrolled in a PDA event. 824 hours | $32. This session will present impressive opportunities for the future, such as having pharmaceutical products available on demand, and a vision of potential outcomes if companies can move past the concept of wanting to be a fast second to adopting new technologies moving towards a future of going first together! GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Since the announcement of a public health emergency in January 2020, we are gingerly entering our third year with the hopes of a new normal. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). CUE 2023 will be a celebration of coming together after two years apart. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond Each speaker will introduce us to implementation success stories and encourage a discussion on its application. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. PDA will not be responsible for any costs incurred by registrants due to cancellation. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. These emails are sent by scammers. Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Phone: +1 (760) 322-6100 This session opens our in-depth look at the content of the draft Annex 1. Valet Parking, operated by PMSI, is available at hotel entrance. IG2: Process Validation and Lyophilization. Continued advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. The Covid-19 pandemic taught us that if from one side we need to preserve those quality and safety standards, from another we need to create an ecosystem able to react quickly to unforeseen events. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 [emailprotected], Tel: +1 (301) 656-5900 ext. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. The new Annex 1 revision was recently released! 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 conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting PDA will not be responsible for any costs incurred by registrants due to cancellation. Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. Richard M Johnson, MSc, President and CEO, PDA 11:25 | Development of a Large Volume Delivery System with a Customized Injection Profile (Case Study) Website| Reservations Link. David Booth, PE, Senior Consultant, LMI. D3:Data Integrity Trends, Patterns, and Insights Los Angeles International Airport (LAX) is 124 miles from the Convention Center. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards No credits will be given for cancellation requests received less than 30 days before the event. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Amy Hartl, PhD, Director of Process Development, SHL Medical Tel: +1 (301) 656-5900 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. Palm Springs, CA Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference explores the future of pharmaceutical devices. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. ABRF 2020, Palm Springs, California ABRF 2019, San Antonio Texas ABRF 2018, Myrtle Beach, South Carolina ABRF 2017, San Diego, California ABRF 2016, Ft. Lauderdale, Florida ABRF 2015, St. Louis, Missouri Interested in becoming a sponsor? The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. What if formulations could be synthesized when and where they are needed? Copyright Parenteral Drug Association. 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 Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Interested in becoming a sponsor? Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma 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. Radish Lot, 04 hours | $9 Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors Iain Simpson,Commercial Director, Phillips-Medisize. PDA 2022 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. She will verify your status and register you. 13507 - Berlin, Germany The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Collaboration and Commitment Can Lead to Awe-Inspiring Results 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Learn about opportunities and benefits. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. 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.
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