The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 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. Radish Lot, 8-24 hours | $19 Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. IG3: Quality Risk Management and GXP Auditing. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 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. Please contact us if you are entiteld to receive a discount. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 After this date, reservations can be made on a space-and-rate available basis only. 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?. This session will discuss the latest developments in industry standardization. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Diego Zurbriggen, Sr. With a proven track record of success, our global and diverse team understands the importance of an international, coordinated approach in this highly specialized sector. Other discounts cannot be applied. 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 . Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Bethesda, MD 20814 USA Juan Cheng, Principal Scientist, Merck & Co., Inc. Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Radish Lot, 48 hours | $13 The points-to-consider paper that our team is developing should be published at about this time. 13:00 14:15 | P3: Premises and Barrier Systems With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Los Angeles International Airport (LAX) is 124 miles from the Convention Center. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. These emails are sent by scammers. The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins 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 Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. 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. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. Using Regulatory Grade CM&S of a Drug Delivery Systems to Accelerate Device Development Statements claiming to offer our attendee lists are fraudulent. This opening plenary features keynotes from two senior biopharmaceutical leaders. This is the final workshop in a series that PDA has hosted in 2022 to educate and help the industry implement the new Annex 1 revision. 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 Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Estimated Taxi Fare 7 USD (one way). All rights reserved. The New Normal in Injectable Drug Delivery. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. Herve Soukiassian, Ass. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. Learn about opportunities and benefits. 13507 - Berlin, Germany You must have this confirmation letter to be considered enrolled in a PDA event. Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH, C2: Transforming Product and Process Knowledge Acquisition to Become More Agile The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Please contact us if you are entiteld to receive a discount. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. After this date, reservations can be made on a space-and-rate available basis only. Tel: +65 64965504 Greyhound: The nearest Greyhound station is located at 205 S Lamar St. 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 Weve come together to create effective tools to fight a global pandemic. decide if a child protection plan should be drawn up for your child. Gregg Peterson, MA, CEO, Bexson Biomedical App based rides are available to/from the airport. March 2-3, 2023. Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. 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 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 Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. Interested in becoming an exhibitor? Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. 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. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. These emails are sent by scammers. 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. 08:00 | Day 1 Report Out 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. 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. Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Other discounts cannot be applied. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Self Parking Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 For more details visit the concerence website . Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Check-in time is 16:00; check-out time is 11:00. It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Jake Keeler, Sr. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! 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. The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone 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. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Max Fill Volume Evaluation for Pre-filled Syringes The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. 10:45 | Strategies for Total Contamination Control in an Aseptic Environment If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Amy Hartl, PhD, Director of Process Development, SHL Medical We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. CG Global Metals & Mining Conference. 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 Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. A Novel Device for Reconstitution and Administration We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. In and out privileges for overnight guests only, operated by PMSI. Lets discuss advances in the use of AI in automated visual inspection. Taxi fares from DAL are approximately $20-25 one way, not including tip. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 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. 10:15 | Aseptic Processing 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. John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach 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 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 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. Interested in becoming an exhibitor? Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing May 18-19, 2023. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Moderator: Theresa E. Bankston, PhD, VP Customer Success, BD, 15:45 | Digital Healthcare in Drug Delivery: The Pillars of Hardware and Software to Empower the End User October 11, 2022. [emailprotected], 4350 East West Highway, Suite 600 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. This Hotel does not offer shuttle service. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. These emails are sent by scammers. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 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. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 PDA will not be responsible for any costs incurred by registrants due to cancellation. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Palm Springs, CA. The rate is $249 for single or double occupancy. The group rate is $199 for single or double occupancy. What if formulations could be synthesized when and where they are needed? Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. 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. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series Cancellation requests must be emailed to [emailprotected]. 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 Palm Springs, CA, 400 East Tahquitz Canyon Way Please call 214 849 6831 for bus information. All rights reserved. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. 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. The Beneficial Feedback Loop of the Digital Twin Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. 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. Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. It's time to come together and celebrate all that is good about being an educator. 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. Moderator: Manfred Maeder, Head Device Dev. Peter Holst, Co-Founder and CEO, FPrin, LLC. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity 10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. May 15-17, 2022. 888 Tahquitz Canyon Way Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. An Insight from PFS Manufacturing for AI Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. 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. Join us in Palm Springs for the ultimate educator experience! Moderator: Marc Glogovsky, MS, S.M. No credits will be given for cancellation requests received less than 30 days before the event. Humberto Vega, PhD, Sr. Director - Ext. Please contact us if you are entiteld to receive a discount. Cancellation requests must be emailed to [emailprotected]. 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 Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford.
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