Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Collaboration and Commitment Can Lead to Awe-Inspiring Results Key learnings and best practices in partnering will be openly discussed. 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. Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Discuss market, industry trends and new technologies. Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. 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 It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group Yashvinder Sabharwal, PhD, Chief Executive Officer, CherryCircle Software, Inc. 16:20 | The Digital Gap in the Pharma Industry: Effects in Patients and the Recipe to Succeed in the Journey 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 Cancellation requests must be emailed to [emailprotected]. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Parking at the Convention Center costs $10 daily. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. 10:45 | Strategies for Total Contamination Control in an Aseptic Environment Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. 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. 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 Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Subsequently, we will focus on best practices to validate the method using multivariate approach. The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring (This applies in particular to costs for submitting documents by courier.). Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. She will verify your status and register you. Continued advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. Self Parking Consider the possibilities: Please contact us if you are entiteld to receive a discount. We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Tel: +49 30 436 55 08-0 or -10 Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 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. CUE 2023 will be a celebration of coming together after two years apart. [emailprotected], Tel: +1 (301) 656-5900 ext. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System Accommodation requests must be made no later than 18 March 2022. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. Palm Springs, CA Tel: +49 30 436 55 08-0 or -10 Website| Reservations Link. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing). IG3: Quality Risk Management and GXP Auditing. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Join us for our global Metals and Mining conference bringing together . Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems. PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole. 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. Toni Manzano, PhD, CSO and Co-Founder, Aizon. Overnight Guests |$32 + tax Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? Ontario International airport (ONT) is 70 miles from the Convention Center. Video, photo, and audio recordings are prohibited at all PDA events. The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. 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. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective The first speaker will provide experimental results obtained from comparing both glass and polymer silicone-free container closure systems in terms of functional performance and drug stability. With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. 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 Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger 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. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Moderator: Manfred Maeder, Head Device Dev. Los Angeles International Airport (LAX) is 124 miles from Hotel. Tel: +65 64965504 Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. Bethesda, MD 20814 USA Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 Copyright Parenteral Drug Association. All rights reserved. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings Xi Zhao, Senior Scientist, Merck & Co., Inc. BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. App based rides are available to/from the airport. May 15-17, 2022. 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. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Interested in becoming an exhibitor? Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Valet Parking Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User Video, photo, and audio recordings are prohibited at all PDA events. Visit us at booth 113. The challenges of new product introduction and support of existing products require that companies be aware of new developments. CG Global Metals & Mining Conference. CUE 2023 will . These emails are sent by scammers. Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Individuals will be responsible for payment of their own cancellation fees. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. The agenda is available! Technological evolution and introduction of novel technologies are required to meet these patient needs. To make reservations, individuals should click on the reservation link above. Cancellation requests must be emailed to [emailprotected]. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Amanda M. McFarland, BS, Senior Consultant, ValSource Inc. 10:20 | Aseptic Process Simulations 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. Learn about opportunities and benefits. The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Tel: +1 (301) 656-5900 Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca The 2022 PDA Annual Meeting promises to have something for everyone! B-Lot, 8-24 hours | $19 In this session, attendees will hear insights and analyses from three experts who have reviewed industry data trends in the areas of data integrity, regulatory observations, and recalls. 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. Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic 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. Taxi fares from DFW are approximately $45-50 one way, not including tip. PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. 08:30 10:00 | P3 This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing together industry experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends in this exciting area. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 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. A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. We will highlight whats in store for the future of pharmaceutical manufacturing. Interested in becoming an exhibitor? 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. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System [emailprotected], 4350 East West Highway, Suite 600 08:00 | Welcome Remarks from Workshop Co-Chair (This applies in particular to costs for submitting documents by courier.). Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Gregg Peterson, MA, CEO, Bexson Biomedical (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development This session will provide insight on critical design principles during the development of a (large volume) autoinjector, including real-time assessments to share important learnings from industry leaders. Oct 12, 2022. Palm m105 was a nice device for its time, it had a grayscale screen with a "stunning" 160x160px resolution and a 16 MHz Motorola CPU. Tel: +1 (301) 656-5900, Am Borsigturm 60 After the event, Agle will sign books and the Modernism Week 2022 commemorative posters he designed, pictured above. The rate is $249 for single or double occupancy. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. IG5: Packaging Science Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. D3:Data Integrity Trends, Patterns, and Insights After this date, reservations can be made on a space-and-rate available basis only. 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. $18. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes You must have this confirmation letter to be considered enrolled in a PDA event. 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company 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 ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) C3: Responding to Patient Needs A1: Game Plan: Progress to the Next Stage of Contamination Control Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Juan Cheng, Principal Scientist, Merck & Co., Inc. Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company 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). 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 Please contact us if you are entiteld to receive a discount. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. You can't miss the closing session "Investing in the Future," featuring Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, and James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Tel: +1 (301) 656-5900, Am Borsigturm 60 Gore & Associates, Breakfast 2: Device Platforms 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! Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. Characterizations of Plunger Stopper Movement Rob Hall, Design Team Manager - Product Design, Owen Mumford. 3 to 4 p.m. Feb. 20. Palm Springs, CA, 1300 Tahquitz Canyon Way Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) Young Harris, GA. Moderator: Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company, 13:30 | Seven Key Pillars of Successful Connected Injection Device Development
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