13507 - Berlin, Germany All costs incurring in connection with visa affairs shall be borne by registrants. Weve come together to create effective tools to fight a global pandemic. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. This Conference will focus on the theme to Level Up: Agility in the New Normal! Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. 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. All costs incurring in connection with visa affairs shall be borne by registrants. 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment B-Lot, 8-24 hours | $19 Estimated Taxi Fare 7 USD (one way). The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. Discuss market, industry trends and new technologies. 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. 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. For more details visit the concerence website . Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Thomas James, Mechanical Engineer, Key Tech Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Video, photo, and audio recordings are prohibited at all PDA events. decide how to keep your child safe. B-Lot, 48 hours | $13 Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 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. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction 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. 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 What about equipment that can be incorporated into predesigned modular facilities? Radish Lot, 48 hours | $13 Ugljesa Babic, Junior Project Manager, Schott Schweiz AG. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Bethesda, MD 20814 USA Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Gore & Associates, Breakfast 2: Device Platforms Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. . Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations We call on the government to honour its three year promise to abolish so called 'no fault' evictions and we also call for the instatement of an evictions moratorium. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Check-in time is 16:00; check-out time is 11:00. Phone: +1 (760) 322-6100 D3:Data Integrity Trends, Patterns, and Insights Bethesda, MD 20814 USA 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 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. 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 15:30 | Water Systems and Other Critical Utilities The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference What if formulations could be synthesized when and where they are needed? 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. 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. Peter Gompper, MSc, MBA, Co-founder, Rubitel, An Iterative Process Utilizing Real World Data Collection to Improve Support for Patients with Diabetes Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 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. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. 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. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Palm Springs, CA. Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID PDA 2022 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Phone: +1 (214) 651-1234. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status. Accommodation requests must be made no later than 18 March 2022. Moderator: Manfred Maeder, Head Device Dev. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process. [emailprotected], Tel: +1 (301) 656-5900 ext. Incorporating Sustainability Considerations Within the Device Selection Process 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study Amy Hartl, PhD, Director of Process Development, SHL Medical Connecting People, Science and Regulation. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus 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. Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. 08:30 10:00 | P3 No credits will be given for cancellation requests received less than 30 days before the event. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success 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. [emailprotected], 4350 East West Highway, Suite 600 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. Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. Reut Atarot, Systems Engineering Manager, West Pharmaceutical Services, Inc. 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A4: Patient-Driven Collaborations and New Delivery Technologies BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA Other vaccine platforms and manufacturing technologies that have received less attention will also be important in the future to produce vaccines that can be rapidly manufactured at a low cost, with characteristics needed for easy storage and distribution. 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. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Events | CHDI Foundation Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Metals and mining is in our DNA. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Characterizations of Plunger Stopper Movement [emailprotected], Tel: +49 (0) 30 43 655 08-10 CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand 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. On-site Parking is 35 USD daily. Lee Leichter, RAC, MBA, President, P/L Biomedical. PDA 2022 | Cambridge Pharma If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. Moderator: Marc Glogovsky, MS, S.M. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Learn about opportunities and benefits. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond The group rate is $199 for single or double occupancy. 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring 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 Learn about opportunities and benefits. 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. Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). 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. (This applies in particular to costs for submitting documents by courier.). John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach Amin Sedighiamiri, PhD, Associate Director, AstraZeneca, 13:50 | Addressing Primary Container Challenges in Autoinjector Drug Delivery: Interim Results of a Multiphase Bioburden Study for a Cartridge-Based Autoinjector PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. March 2-3, 2023. 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. 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. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. 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. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone This airport is serviced by numerous carriers. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Michael de la Torre, CEO, Redica Systems. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Other discounts cannot be applied. 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). We will highlight whats in store for the future of pharmaceutical manufacturing. 13:00 | Container Closure Integrity Testing and Finishing Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. 2022 Annual Meeting and Workshops Registration | Society of Tel: +49 30 436 55 08-0 or -10 You must have this confirmation letter to be considered enrolled in a PDA event. Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 Cancellation requests must be emailed to [emailprotected]. 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 conference gives Georgia-based nursing educators an opportunity to come together and learn about issues and trends related to nursing education in their state. 08:00 | Welcome Remarks from Workshop Co-Chair All rights reserved. Learn about opportunities and benefits. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. The 2022 PDA Annual Meeting promises to have something for everyone! Reservations must be secured by Friday, 04 March 2022. Compared to it, Palm TX looks much better it was . Tel: +65 64965504 If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Palm Springs, CA, 1300 Tahquitz Canyon Way 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 A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Valet Parking, operated by PMSI, is available at hotel entrance. After this date, reservations can be made on a space-and-rate available basis only. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 This session will expand on the regulatory challenges we have endured and how we anticipate the future. The Art of Filling and Processing a Pre-filled Syringe 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). The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. Ypsomed is presenting a brand . Sheldon Moberg, MA, SVP Drug Delivery, Bexson Biomedical, 14:10 | A Patient-Centered Approach to Development of Novel On-Body Drug-Delivery Solutions for Injectable Biologics: A Study with Multiple Target Groups Learn about opportunities and benefits. Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. Regulatory agencies have released new policies, flexibilities in procedures, and updates to guidances on the fly, but what are the lasting impact of these changes on our "new normal?. PDA Announces Nearly 100 Exhibitors at the 19th Universe of Pre-Filled Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Modernism Week, celebrating Midcentury Modern design, returns to Palm 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 PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 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. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Jake Keeler, Sr. Other discounts cannot be applied. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? The agenda is available! ABRF Annual Meeting - Association of Biomolecular Resource Facilities Juan Cheng, Principal Scientist, Merck & Co., Inc. 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 Statements claiming to offer our attendee lists are fraudulent. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. [emailprotected], Tel: +1 (301) 656-5900 ext. 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 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. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Get in touch with Aenova and contact us here ! PDA Conference 2022 | Recipharm Join us for our global Metals and Mining conference bringing together . PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. You must have this confirmation letter to be considered enrolled in a PDA event. 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.
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