The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. All costs incurring in connection with visa affairs shall be borne by registrants. Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. 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. 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. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. 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. Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. With your valuable input, we can determine if there is value in having a deeper discussion (i.e., potential PDA project) around this idea of integrating, coordinating, prefabricating, or even prequalifying critical components of a facility ahead of the construction. This airport is serviced by numerous carriers. James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. 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. 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. Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces If there's a child protection conference for your child May 18-19, 2023. Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. 08:30 10:00 | P3 decide how to keep your child safe. Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. CUE 2023 will be a celebration of coming together after two years apart. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Guestroom rates are subject to State and Local taxes. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 What about equipment that can be incorporated into predesigned modular facilities? Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. 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 In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. 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 The points-to-consider paper that our team is developing should be published at about this time. After two years, the return to normal is still uncertain. 2022 PDA Annex 1 Workshop Palm Springs | Speakers If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 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. All rights reserved. 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. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. Lee Leichter, RAC, MBA, President, P/L Biomedical. 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. Ontario International airport (ONT) is 70 miles from the Convention Center. 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. 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles Los Angeles International Airport (LAX) is 124 miles from Hotel. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Palm Springs Symposium on HIV/AIDS - Cancer Research Institute Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. 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. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective Jake Keeler, Sr. 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. Philip A. Villari, MS, Associate Principal Scientist, Merck & Co., Inc. 11:25 | A Rapid Microbial Detection Technology to Identify Water Purification Failures in Real Time Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Video, photo, and audio recordings are prohibited at all PDA events. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! : New Technology Facilitating Process-Product Communication Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity Collaboration and Commitment Can Lead to Awe-Inspiring Results Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics You must have this confirmation letter to be considered enrolled in a PDA event. The rate is $249 for single or double occupancy. The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. Oct 12, 2022. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. October 18-19, 2022 Palm Springs, CA Booth #606. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone 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. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. Finally, we will learn about regulatory considerations. Join us in Palm Springs for the ultimate educator experience! 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. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. 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. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. This Conference will focus on the theme to Level Up: Agility in the New Normal! The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Tel: +1 (301) 656-5900 Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. Characterizations of Plunger Stopper Movement Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. 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 These emails are sent by scammers. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Xi Zhao, Senior Scientist, Merck & Co., Inc. John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Cancellation requests must be emailed to [emailprotected]. PDA will not be responsible for any costs incurred by registrants due to cancellation. 13507 - Berlin, Germany Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia This session will also address the expanded scope of Annex 1 to include some non-steriles. The 2022 PDA Annual Meeting promises to have something for everyone! 08:00 | Welcome Remarks from Workshop Co-Chair Palm Springs, CA Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. 13507 - Berlin, Germany Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) Ugljesa Babic, Junior Project Manager, Schott Schweiz AG. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Parking at the Convention Center costs $10 daily. Consider the possibilities: Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Michael de la Torre, CEO, Redica Systems. Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. To make reservations, individuals should click on the reservation link above. 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 Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. An Insight from PFS Manufacturing for AI 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 . Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems 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?. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device 13:00 14:15 | P3: Premises and Barrier Systems 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. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. 10:15 | Aseptic Processing Tom Mayer, MBA, Business Unit Manager, Sonceboz SA A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. Radish Lot, 48 hours | $13 PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies. Young Harris, GA. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing Sbastien Cordier, Technical Product Manager, Aptar Pharma, From the Users Perspective: The Use of Eye Tracking Technology in Human Factors Studies to Assess and Improve Injection Device Usability