10:45 | Process Intensification of Cell-Based Vaccine Manufacturing 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring decide if a child protection plan should be drawn up for your child. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. Bethesda, MD 20814 USA Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Palm Springs, CA [emailprotected], 4350 East West Highway, Suite 600 A1: Game Plan: Progress to the Next Stage of Contamination Control Thomas James, Mechanical Engineer, Key Tech [emailprotected], Tel: +1 (301) 656-5900 ext. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! 08:30 10:00 | P3 Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Join us in Palm Springs for the ultimate educator experience! 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone Young Harris, GA. 824 hours | $32. March 2-3, 2023. Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG, 07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components Parking at the Convention Center costs $10 daily. 15:00 | Environmental and Process Monitoring The rate is $249 for single or double occupancy. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain 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 HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Tel: +1 (301) 656-5900 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. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. DART Light Rail Service: The hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. 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 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. 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. Subsequently, we will focus on best practices to validate the method using multivariate approach. 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. This session will discuss the latest developments in industry standardization. Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability 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 Los Angeles International Airport (LAX) is 124 miles from Hotel. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. In this Interest Group Meeting, participants will discuss PDA Technical Report No. 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 She will verify your status and register you. 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. 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. The biopharmaceutical industry has evolved from traditional vaccines and therapeutic proteins to encompass a broad range of modalities, including mRNAs, cell therapies, and other advanced therapeutic medicinal products. All costs incurring in connection with visa affairs shall be borne by registrants. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. 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. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. 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. 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 Statements claiming to offer our attendee lists are fraudulent. 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). Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG 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. 15:30 | Water Systems and Other Critical Utilities Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. What about equipment that can be incorporated into predesigned modular facilities? Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Please contact us if you are entiteld to receive a discount. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing [emailprotected], 4350 East West Highway, Suite 600 Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. Phone: +1 (214) 651-1234. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 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. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. Humberto Vega, PhD, Sr. Director - Ext. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID 115 A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities. Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. Valet Parking, operated by PMSI, is available at hotel entrance. $18. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Oct 12, 2022. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? 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. Michael de la Torre, CEO, Redica Systems. The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. 10:45 | Data Integrity Trends in 2021 Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization 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 (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development (This applies in particular to costs for submitting documents by courier.). 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. Characterizations of Plunger Stopper Movement 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings (This applies in particular to costs for submitting documents by courier.). Reservations must be secured by Friday, 30 September 2022. 115 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) IG3: Quality Risk Management and GXP Auditing. 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 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations (NRCM), Senior Consultant Microbiology, ValSource Inc. Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. 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. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. 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 Herve Soukiassian, Assoc. BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA [emailprotected], 4350 East West Highway, Suite 600 B-Lot, 8-24 hours | $19 Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. Tel: +1 (301) 656-5900, Am Borsigturm 60 Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Tel: +65 64965504 Bethesda, MD 20814 USA 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. 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
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