It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Dr. Forster will also elaborate on how to leverage insights derived from other industries. Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. In January 2020, the first U.S. case of COVID-19 was confirmed, declared a pandemic in March, and by April, nearly half of the world's population was under lockdown. Phone: +1 (214) 651-1234. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Thomas James, Mechanical Engineer, Key Tech For later registrations, PDA Europe will be unable to assist participants in any visa affairs. October 18, 2022 - October 19, 2022. Finally, we will learn about regulatory considerations. 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. 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. Palm Springs, CA, 1300 Tahquitz Canyon Way Come and visit us in Booth #222 & 224. Michael de la Torre, CEO, Redica Systems. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. Stefano Pilati, Technical Evaluation and Product Development Coordinator, Stevanato Group, How to Leverage Your Device Supply Chain and Bring Unique Combination Products and Medical Devices to Market Quicker 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. Palm Springs Convention Center. The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. 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. 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 . Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. 15:30 | Water Systems and Other Critical Utilities Radish Lot, 04 hours | $9 Los Angeles International Airport (LAX) is 124 miles from Hotel. These emails are sent by scammers. B-Lot, 8-24 hours | $19 The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Join us for our global Metals and Mining conference bringing together . Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. After this date, reservations can be made on a space-and-rate available basis only. C3: Responding to Patient Needs 04 hours | $22 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. These emails are sent by scammers. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . [emailprotected], 4350 East West Highway, Suite 600 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. No credits will be given for cancellation requests received less than 30 days before the event. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. 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 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. Consider the possibilities: App based rides are available to/from the airport. At the completion of this workshop, participants will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. You must have this confirmation letter to be considered enrolled in a PDA event. 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. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. October 18-19, 2022 Palm Springs, CA Booth #606. Characterizations of Plunger Stopper Movement Iain Simpson,Commercial Director, Phillips-Medisize. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 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. We will highlight whats in store for the future of pharmaceutical manufacturing. Bethesda, MD 20814 USA [emailprotected], Tel: +49 (0) 30 43 655 08-10 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. Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems Marty Coyne, BEME, MBA, Principal, Matchstick LLC, 14:10 | Integrating Secure and Easy to Handle Connectivity into a Pre-Filled Device for Automated Injection Logging Reservations must be secured by Friday, 04 March 2022. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. (This applies in particular to costs for submitting documents by courier.). [emailprotected], Tel: +1 (301) 656-5900 ext. 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. What if formulations could be synthesized when and where they are needed? Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. 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 Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. In this Interest Group Meeting, participants will discuss PDA Technical Report No. Keep an eye out for John Burke, Chris Hurlstone, Alastair Willoughby and Andy Fry to find out how Team Consulting could support your next parenteral device development. Tel: +1 (301) 656-5900 If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Naresh K. Budhavaram, PhD, Senior Consultant Engineer, Eli Lilly and Company, 16:05 | Assessing the Environmental Impact of Global Supply Chain Logistics and Supplier Selection for Injection Devices Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. 08:00 | Day 1 Report Out Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Amanda M. McFarland, BS, Senior Consultant, ValSource Inc. 10:20 | Aseptic Process Simulations This session will expand on the regulatory challenges we have endured and how we anticipate the future. Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) IG6: Microbiology/ Environmental Monitoring Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond 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. 15:00 | Environmental and Process Monitoring 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. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference explores the future of pharmaceutical devices. Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics 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. IG1: Biopharmaceutical Manufacturing Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus CG Global Metals & Mining Conference. Young Harris, GA. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing All rights reserved. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization Ontario International airport (ONT) is 70 miles from Hotel. Accommodation requests must be made no later than 18 March 2022. Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 15:55 | Q&A and Final Discussion with Additioanl Panelists and Commercialization, Device Dev/Commercialization, Novartis International AG, 13:30 | Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Product Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations Consideration of Needle Insertion Depth in Subcutaneous Drug Delivery Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Taxi fares from DFW are approximately $45-50 one way, not including tip. 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. B2: New Technologies in Bioprocessing Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors 824 hours | $32. Estimated Taxi Fare 7 USD (one way). Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Please contact us if you are entiteld to receive a discount. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. 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 Copyright Parenteral Drug Association. Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger Reservations must be secured by Friday, 30 September 2022. 277 N. Avenida Caballeros Video, photo, and audio recordings are prohibited at all PDA events. The trend to move therapies to the home setting has been known for some time but the pandemic has accelerated and changed drug formulation strategies. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). She will verify your status and register you. Get in touch with Aenova and contact us here ! 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. 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. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. 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. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing 13:00 13:50 | P7: Production Technologies, Part 2 Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
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