GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. What about equipment that can be incorporated into predesigned modular facilities? Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. 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. All costs incurring in connection with visa affairs shall be borne by registrants. 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. 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms Regulatory agencies have released new policies, flexibilities in procedures, and updates to guidances on the fly, but what are the lasting impact of these changes on our "new normal?. This session opens our in-depth look at the content of the draft Annex 1. The Palm Springs workshop, 20-21 Oct., is the fourth sponsored by PDA in 2022. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. 08:00 | Welcome Remarks from Workshop Co-Chair Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices The rate is $249 for single or double occupancy. Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) Radish Lot, 8-24 hours | $19 Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma There is an enormous amount of data being collected today, but what does it all mean? 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Statements claiming to offer our attendee lists are fraudulent. Gregg Peterson, MA, CEO, Bexson Biomedical 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 . This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . October 11, 2022. Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Compared to it, Palm TX looks much better it was . If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). After this date, reservations can be made on a space-and-rate available basis only. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Come and visit us in Booth #222 & 224. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. (This applies in particular to costs for submitting documents by courier.). Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices Palm Springs, CA. Individuals will be responsible for payment of their own cancellation fees. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit [emailprotected], Tel: +49 (0) 30 43 655 08-10 It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Palm Desert, CA. In and out privileges for overnight guests only, operated by PMSI. 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. This session will discuss the latest developments in industry standardization. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. 13507 - Berlin, Germany George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. Jeffrey Givand, PhD, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Commercialization, Device Dev/Commercialization, Novartis International AG, 13:30 | Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Product How was it done, what were the barriers, the learnings, and how could it be done so fast? 16:40 | What If Sterile Product Processing Equipment Could Talk? All costs incurring in connection with visa affairs shall be borne by registrants. William G. Whitford, Life Science Strategic Solutions Leader, DPS Group, 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Subsequently, we will focus on best practices to validate the method using multivariate approach. 48 hours| $26 We call on the government to honour its three year promise to abolish so called 'no fault' evictions and we also call for the instatement of an evictions moratorium. Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA 13:00 14:15 | P3: Premises and Barrier Systems John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain 08:30 10:00 | P3 Key learnings and best practices in partnering will be openly discussed. A1: Game Plan: Progress to the Next Stage of Contamination Control 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 airport is serviced by numerous carriers. App based rides are available to/from the airport. 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. 115 Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Rob Hall, Design Team Manager - Product Design, Owen Mumford. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? Ontario International airport (ONT) is 70 miles from Hotel. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? All rights reserved. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development On-site Parking is 35 USD daily. 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. The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. IG5: Packaging Science 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. Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Get in touch with Aenova and contact us here ! 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. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. Agility in development and supply chain builds on good clinical and commercial process design and realization. Bethesda, MD 20814 USA Dallas, TX B2: New Technologies in Bioprocessing Amanda M. McFarland, BS, Senior Consultant, ValSource Inc. 10:20 | Aseptic Process Simulations In and out privileges for hotel guests only. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Finally, we will learn about regulatory considerations. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. B-Lot, 48 hours | $13 In this Interest Group Meeting, participants will discuss PDA Technical Report No. 277 N. Avenida Caballeros 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 Tel: +49 30 436 55 08-0 or -10 [emailprotected], Tel: +49 (0) 30 43 655 08-10 Humberto Vega, PhD, Sr. Director - Ext. Weve come together to create effective tools to fight a global pandemic. This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery 08:00 | Day 1 Report Out Join us for our global Metals and Mining conference bringing together . Palm Springs Convention Center. Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. 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 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. 10:15 | Aseptic Processing 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Amy Hartl, PhD, Director of Process Development, SHL Medical 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! 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. 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. Video, photo, and audio recordings are prohibited at all PDA events. Moderator: Marc Glogovsky, MS, S.M. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia 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. [emailprotected], Tel: +1 (301) 656-5900 ext. For more details visit the concerence website . 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 Michael de la Torre, CEO, Redica Systems. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing Technological evolution and introduction of novel technologies are required to meet these patient needs. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings Bethesda, MD 20814 USA (This applies in particular to costs for submitting documents by courier.). Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. The Interest Group will be discussing the recently launched a survey on process validation approaches. Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Advisor, Kymanox, 08:30 | The COVID-19 Vaccine Development Story Taking place in Palm Springs, CA, the Conference will dive into interactive sessions and multiple tracks that will address innovation and regulatory trends in the universe of application device technology and explore what's next for the future of this field. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. 3 to 4 p.m. Feb. 20. 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 This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. 2022 PDA Annex 1 Workshop: Palm Springs Oct 20 - Oct 21, 2022 Frederic B. Ayers 2022 annex 1 palm springs presenter Eli Lilly and Company Fred was a student-athlete at Franklin College of Indiana and participated in the college's Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology. The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Palm Springs, CA, 400 East Tahquitz Canyon Way PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. The pandemic experience typified the need to be prepared for serious unanticipated events. 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. Chuck W. Seipel, Product Specialist, W.L. The ability to rapidly develop and manufacture mRNA vaccines with high efficacy against the SARS-CoV-2 virus is a tremendous public health accomplishment and has spurred widespread interest in mRNA vaccines for multiple infectious diseases and other indications. These emails are sent by scammers. 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. 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C Tel: +1 (301) 656-5900, Am Borsigturm 60 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! Learn about opportunities and benefits. 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 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. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? This session will explore various opportunities for making home drug delivery a reality from smart delivery devices for the home setting, enabling primary containers for single use administration to patient training and on-boarding solutions specifically designed for at-home use. Estimated Taxi Fare 7 USD (one way). Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? It's time to come together and celebrate all that is good about being an educator. Connecting People, Science and Regulation. 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series 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 Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone

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