Statements claiming to offer our attendee lists are fraudulent. 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. Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 15:45 | Hybrid Prefilled Syringes Suitable for Cold Storage Vaccines and Biologic Drugs Without Compromising Container Closure Integrity 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. 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 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. 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. 48 hours| $26 All costs incurring in connection with visa affairs shall be borne by registrants. No refunds will be granted for requests postmarked after April 13, 2022. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. You must have this confirmation letter to be considered enrolled in a PDA event. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions 13:00 14:15 | P3: Premises and Barrier Systems Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Esther Foo, PhD, Senior Scientist, Merck & Co., Inc. 11:25 |Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. In and out privileges for overnight guests only, operated by PMSI. Learn about opportunities and benefits. IG3: Quality Risk Management and GXP Auditing. 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 . Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices Individuals will be responsible for payment of their own cancellation fees. These emails are sent by scammers. The 2022 PDA Annex 1 Workshops highlight critical changes in the new regulation and include interactive sessions to provide attendees with a clear understanding of and means to implement all the requirements of the rule. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. This Conference will focus on the theme to Level Up: Agility in the New Normal! 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. Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. CUE 2023 will be a celebration of coming together after two years apart. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Accommodation may be offered on a case-by-case basis for any in-person participant who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice, unless otherwise provided under applicable state or local law. 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes D3:Data Integrity Trends, Patterns, and Insights Visit us at booth 113. Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) Amy Hartl, PhD, Director of Process Development, SHL Medical 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs : New Technology Facilitating Process-Product Communication HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium Reservations must be secured by Friday, 04 March 2022. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 No credits will be given for cancellation requests received less than 30 days before the event. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. $18. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors 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 May 15-17, 2022. Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event. Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. All rights reserved. PDA Conference October 18th-19th 2022 | Oval Medical Technologies (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Palm Springs, CA. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). 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. Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics PDA Conference 2022 | Recipharm 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. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Self Parking David Booth, PE, Senior Consultant, LMI. The Palm Springs workshop, 20-21 Oct., is the fourth sponsored by PDA in 2022. 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. 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. 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma.