To progress our organizations to the next level, new and innovative ways of thinking need to be employed. The safety and wellbeing of our participants is a top priority for PDA; therefore, we will be implementing the following guidelines for this in-person event: Participants, including attendees, exhibitors, trainers, students, staff, guests, contractors, and vendors, must provide proof of vaccination after registering for an in-person event. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Tel: +49 30 436 55 08-0 or -10 To make reservations, individuals should click on the reservation link above. 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. Michael de la Torre, CEO, Redica Systems. The aim of this conference is to provide the latest information and to . Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. Discuss market, industry trends and new technologies. Learn about opportunities and benefits. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Learn about opportunities and benefits. 15:00 | Environmental and Process Monitoring There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. 115 If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Connecting People, Science and Regulation, Gov./Health Authority/Academic (Member/Non-Member), Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision, Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations. Estimated Taxi Fare 7 USD (one way). The 2022 PDA Annual Meeting promises to have something for everyone! The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. All costs incurring in connection with visa affairs shall be borne by registrants. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success Cancellation requests must be emailed to [emailprotected]. Palm Springs, CA, 400 East Tahquitz Canyon Way 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. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus 04 hours | $22 10:15 | Aseptic Processing 115 Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration PDA Conference October 18th-19th 2022. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Guestroom rates are subject to State and Local taxes. PDA's Universe of Pre-filled Syringes and Injection Devices Conference Palm Springs International Airport (PSP) is 1.5 miles from Hotel. Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. 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. All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. 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. March 2-3, 2023. 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. 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. Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group), Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System A1: Game Plan: Progress to the Next Stage of Contamination Control Chuck W. Seipel, Product Specialist, W.L. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger (This applies in particular to costs for submitting documents by courier.). 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 A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. Tel: +49 30 436 55 08-0 or -10 Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. 277 N. Avenida Caballeros 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. 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. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. IG8: Facilities and Engineering 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. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. Leader: Susan M. Dounce, PhD, Director Commercial Technology Development, West Pharmaceutical Services, Inc. [emailprotected], Tel: +49 (0) 30 43 655 08-10 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. At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 2022 PDA Annual Meeting Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. 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. 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 No credits will be given for cancellation requests received less than 30 days before the event. This opening plenary features keynotes from two senior biopharmaceutical leaders. Bethesda, MD 20814 USA Self Parking The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness What if formulations could be synthesized when and where they are needed? Jason J. Orloff, ChE, Principal Engineer and Statistician, PharmStat, 11:25 | Continuous Bioprocessing: Regulatory Harmonization and Industry Best Practices Quality and Regulatory Shifts Driving Implementation of Flexible Biopharmaceutical Manufacturing Systems Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. This Conference will focus on the theme to Level Up: Agility in the New Normal! Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Additional workshops are anticipated for 2023. Interested in becoming an exhibitor? Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Tel: +65 64965504 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. Dr. Forster will also elaborate on how to leverage insights derived from other industries. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be live in Palm Springs from the 18th-19th October and we're looking forward to seeing you there. Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. In this session, the speakers will provide insight into modern microbial methods by discussing the validation process and regulatory acceptance for an automated colony counter utilizing a cross functional industry team, navigating speedbumps throughout implementation of a biofluorescent particle counting system, and a case study on rapid microbial detection for a purified water system. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. [emailprotected], Tel: +1 (301) 656-5900 ext. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Jake Keeler, Sr. 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Tel: +1 (301) 656-5900, Am Borsigturm 60 Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. We will conclude by reviewing the shared vision from a cross-industry collaboration. Los Angeles International Airport (LAX) is 124 miles from Hotel. Interested in becoming a sponsor? Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. 13:00 13:50 | P7: Production Technologies, Part 2 Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes 2022 edition of PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be held at Palm Springs Convention Center, Palm Springs starting on 18th October. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 18/10/2022 - 19/10/2022 Palm Springs, CA. Marc Glogovsky, MS, S.M. 10:45 | Strategies for Total Contamination Control in an Aseptic Environment This Hotel does not offer shuttle service. The Art of Filling and Processing a Pre-filled Syringe Visit us at booth 113. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices
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