Fax: +65 6496 5599, Manager Registration, Chapters & Membership. Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. This Conference will focus on the theme to Level Up: Agility in the New Normal! Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. 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). Radish Lot, 04 hours | $9 Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 The 2022 PDA Annual Meeting promises to have something for everyone! 13:00 13:50 | P7: Production Technologies, Part 2 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. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Diego Zurbriggen, Sr. Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training 300 Reunion Boulevard Overnight Guests |$32 + tax Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Phone: +1 (214) 651-1234. D3:Data Integrity Trends, Patterns, and Insights Tel: +1 (301) 656-5900 Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Palm Springs, CA. Lynne Liao, Senior Engineer I, Alexion Pharmaceuticals, 13:50 | Advancements in Fully Robotic No-Touch-Transfer Solutions Used to Introduce RTU Containers into Aseptic Isolators, Enhancing Contamination Control and Sterility Assurance 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms 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. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment. This airport is serviced by numerous carriers. Tel: +65 64965504 PDA will not be responsible for any costs incurred by registrants due to cancellation. 08:30 10:00 | P3 There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. A1: Game Plan: Progress to the Next Stage of Contamination Control Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG. Thomas James, Mechanical Engineer, Key Tech Herve Soukiassian, Ass. The Interest Group will be discussing the recently launched a survey on process validation approaches. Tel: +49 30 436 55 08-0 or -10 Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Ulrich Kllisch, PhD, Manager Data Integrity, GxP-CC, 11:05 | A Deep Dive into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices 888 Tahquitz Canyon Way A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Technological evolution and introduction of novel technologies are required to meet these patient needs. Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. IG3: Quality Risk Management and GXP Auditing. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Taxi fares from DAL are approximately $20-25 one way, not including tip. Interested in becoming a sponsor? 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. Moderator: Mathias Romacker, Executive Advisor,Kymanox. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLCand Co-Chair, 2022 PDA Annual Meeting, 13:30 | Jeffrey C. Baker, PhD, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Video, photo, and audio recordings are prohibited at all PDA events. 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 John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach 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. 15:30 | Water Systems and Other Critical Utilities These emails are sent by scammers. This Hotel does not offer shuttle service. 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. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform 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. 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Self Parking With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. Interested in becoming a sponsor? 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 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. Characterizations of Plunger Stopper Movement No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. A Novel Device for Reconstitution and Administration By eliminating the need for silicone in both the barrel and . Please contact us if you are entiteld to receive a discount. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator 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 IG8: Facilities and Engineering 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms In this cant-miss closing session, Don Jones and Jim Collins will provide insight into how the drug delivery, device, and connected care market is evolving, and how the key trends might be evaluated for investment by delivery device and biopharmaceutical companies. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success This session will present impressive opportunities for the future, such as having pharmaceutical products available on demand, and a vision of potential outcomes if companies can move past the concept of wanting to be a fast second to adopting new technologies moving towards a future of going first together! To progress our organizations to the next level, new and innovative ways of thinking need to be employed. Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing Amy Hartl, PhD, Director of Process Development, SHL Medical For more details visit the concerence website . The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. After two years, the return to normal is still uncertain. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Individuals will be responsible for payment of their own cancellation fees. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. 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. 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 If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA In this session, speakers will share best practices for container integrity important for vaccine distribution and quality by design principles applied in viral product development. 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. The focus of this Interest Group will be to discuss different approaches and methodologies to increase our ability to cut down the time it takes to get to market. 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. 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. Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success Conferences in Palm Springs Category 1 filter applied Conference Clear All DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) Thu, Jun 1, 6:00 PM Private Hotel - NEW location Palm Springs, CA 57th Annual State Women's Convention David Booth, PE, Senior Consultant, LMI. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. 2022 PDA Annex 1 Workshop: Palm Springs Oct 20 - Oct 21, 2022 Frederic B. Ayers 2022 annex 1 palm springs presenter Eli Lilly and Company Fred was a student-athlete at Franklin College of Indiana and participated in the college's Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology. With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. 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. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 16:40 | What If Sterile Product Processing Equipment Could Talk? Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. 115 Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. 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 This session opens our in-depth look at the content of the draft Annex 1. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability 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. Marc Glogovsky, MS, S.M. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. Please call 214 653 1101 for train information. 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy 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 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. Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. 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 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. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. Copyright Parenteral Drug Association. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Interested in becoming a sponsor? Metals and mining is in our DNA. 10:15 11:20 | P6: Production Technologies, Part 1 Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Advisor, Kymanox, 08:30 | The COVID-19 Vaccine Development Story The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. October 18, 2022 - October 19, 2022. 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination 10:45 | Strategies for Total Contamination Control in an Aseptic Environment 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. After this date, reservations can be made on a space-and-rate available basis only. 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. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 15:55 | Q&A and Final Discussion with Additioanl Panelists 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. William G. Whitford, Life Science Strategic Solutions Leader, DPS Group, 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . No credits will be given for cancellation requests received less than 30 days before the event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). This session will discuss the latest developments in industry standardization. 3 to 4 p.m. Feb. 20. The rate is $249 for single or double occupancy. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. Tel: +1 (301) 656-5900, Am Borsigturm 60 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 Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Weve come together to create effective tools to fight a global pandemic. A3: Cleanroom Manufacturing: A New Area Across Technology and Processes Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector To make reservations, individuals should click on the reservation link above. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics 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. 277 N. Avenida Caballeros Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Subsequently, we will focus on best practices to validate the method using multivariate approach. How was it done, what were the barriers, the learnings, and how could it be done so fast? Other discounts cannot be applied. Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. 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. 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. Type: In-personWhen: May 22-26, 2022Where: Palm Springs, California Conference overview: Battelle's 2022 conference for environmental professionals will cover a range of topics including: Dedicated presentations on PFAS issues Innovations and technologies to address chlorinated and recalcitrant compounds in the environment Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger 15:45 | Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, 16:05 | James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC, The following posters will be presented during each break in the Exhibit Hall. At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement (This applies in particular to costs for submitting documents by courier.). Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! 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. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors 2022 PDA Annex 1 Workshop (Palm Springs) Oct 20 - Oct 21, 2022 Palm Springs, CA Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The new Annex 1 revision was recently released! This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements.
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