decide if a child protection plan should be drawn up for your child. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. 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. You must have this confirmation letter to be considered enrolled in a PDA event. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Check-in time is 16:00; check-out time is 11:00. 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. No credits will be given for cancellation requests received less than 30 days before the event. You must have this confirmation letter to be considered enrolled in a PDA event. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Subsequently, we will focus on best practices to validate the method using multivariate approach. The group rate at all hotels is $199 for single or double occupancy. Weve come together to create effective tools to fight a global pandemic. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Iain Simpson,Commercial Director, Phillips-Medisize. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm 115 Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. October 18, 2022 - October 19, 2022. 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 Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Other discounts cannot be applied. Tel: +49 30 436 55 08-0 or -10 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. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Tom Mayer, MBA, Business Unit Manager, Sonceboz SA Please call 214 653 1101 for train information. The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices 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 The Beneficial Feedback Loop of the Digital Twin Reservations must be secured by Friday, 04 March 2022. Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. 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 Tel: +1 (301) 656-5900 Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development 04 hours | $22 If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. This opening plenary features keynotes from two senior biopharmaceutical leaders. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. PDA Conference October 18th-19th 2022. Interested in becoming an exhibitor? 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. This session opens our in-depth look at the content of the draft Annex 1. 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 Reservations must be secured byFriday, 23 September 2022. These emails are sent by scammers. Young Harris, GA. Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. 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. Joerg Stumbaum, Project Manager, PPS&P, Vetter This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Tel: +65 64965504 Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone What about equipment that can be incorporated into predesigned modular facilities? decide how to keep your child safe. Estimated Taxi Fare 7 USD (one way). Cancellation requests must be emailed to [emailprotected]. 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery 10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Moderator: Marc Glogovsky, MS, S.M. Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. [emailprotected], Tel: +1 (301) 656-5900 ext. Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. 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 To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. 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. 3 to 4 p.m. Feb. 20. PDA Conference 2022 | Recipharm For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Reservations must be secured by Friday, 30 September 2022. 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. With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 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. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company. 2022 PDA Annual Meeting Copyright Parenteral Drug Association. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. 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. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. IG3: Quality Risk Management and GXP Auditing. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. (This applies in particular to costs for submitting documents by courier.). ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) All costs incurring in connection with visa affairs shall be borne by registrants. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics $18. The challenges of new product introduction and support of existing products require that companies be aware of new developments. D1: Building Back Better: Innovative Options for Audits and Inspections This session will also address the expanded scope of Annex 1 to include some non-steriles. 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 Ron Pettis, Director, Translational and Clinical Sciences, BD, 15:00 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall, 15:45 17:30 | P4: Investing in the Future This Conference will focus on the theme to Level Up: Agility in the New Normal! 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. 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. 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 Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Bethesda, MD 20814 USA 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. 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 If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal 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 Humberto Vega, PhD, Sr. Director - Ext. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 ABRF Annual Meeting - Association of Biomolecular Resource Facilities PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 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 Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins [emailprotected], 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA Steven R. Kaufman, MBA, Vice President, Drug Delivery Systems, Stevanato Group, 11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study Bethesda, MD 20814 USA Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Lets discuss advances in the use of AI in automated visual inspection. 300 Reunion Boulevard Learn about opportunities and benefits. October 11, 2022. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia A Novel Device for Reconstitution and Administration 115 John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Find your oasis while lounging beside one of the area's largest outdoor pools or sipping a refreshing drink in one of our private cabanas. Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Richard M Johnson, MSc, President and CEO, PDA (NRCM), Senior Consultant Microbiology, ValSource Inc. Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. David Booth, PE, Senior Consultant, LMI. Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Individuals will be responsible for payment of their own cancellation fees. This will be followed by Amgens Dr. Ronald Forster discussing the merits of developing platform technologies, and how they enable continuous improvement in the patient journey through product quality, innovation, and manufacturing efficiency. 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. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs.
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