The group rate is $199 for single or double occupancy. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. Patrick Grandt, Medical Device Engineer, Genentech, Inc. A Packaging Platform for Pre-Filled Syringes and Self-Injection Devices; How Unit-Level Compliance Can Improve Treatment Outcomes Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting 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. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal 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 Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. 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. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 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. To make reservations, individuals should click on the reservation link above. Bethesda, MD 20814 USA Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Incorporating Sustainability Considerations Within the Device Selection Process (This applies in particular to costs for submitting documents by courier.). Consider the possibilities: Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. Wendy Woodley, Staff Scientist II, BD. Moderator: Mathias Romacker, Executive Advisor,Kymanox. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. No credits will be given for cancellation requests received less than 30 days before the event. We will conclude by reviewing the shared vision from a cross-industry collaboration. You must have this confirmation letter to be considered enrolled in a PDA event. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 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. 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. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond ABRF Annual Meeting - Association of Biomolecular Resource Facilities This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). The conference must talk about all the children in your household, even if the people there are only . Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG, 07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca Self Parking The Beneficial Feedback Loop of the Digital Twin Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. CG Global Metals & Mining Conference - Canaccord Genuity Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes 2022 PDA Annex 1 Workshop Palm Springs | Speakers IG2: Process Validation and Lyophilization. New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain decide how to keep your child safe. 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 May 18-19, 2023. 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product 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. 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. The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. 888 Tahquitz Canyon Way Other discounts cannot be applied. Get in touch with Aenova and contact us here ! 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. 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 Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity Reservations must be secured by Friday, 04 March 2022. Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors 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 Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. 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. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. The agenda is available! The new Annex 1 revision was recently released! Characterizations of Plunger Stopper Movement It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) All costs incurring in connection with visa affairs shall be borne by registrants. Metals and mining is in our DNA. PDA Universe of Pre-Filled Syringes and Injection Devices Conference Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study Visit us at booth 113. In and out privileges for hotel guests only. Palm Springs International Airport (PSP) is 1.5 miles from Hotel. 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. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. 10:45 | Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution: A Best Practice Holistic Science-Based Approach Rudolf Michael Weiss, Dipl.-Ing., Global Head of Pharma+Medical, Stubli, 07:35 | A Real-World Example of Sustainable Drug Delivery the Development of the First Reusable Pen Injector for Concentrated Insulin Top PFAS Conferences in 2022 | News Direct Each speaker will introduce us to implementation success stories and encourage a discussion on its application. It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. Copyright Parenteral Drug Association. Oct 12, 2022. 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. PDA Conference October 18th-19th 2022. 10:15 11:20 | P6: Production Technologies, Part 1 This Conference will focus on the theme to Level Up: Agility in the New Normal! This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. 11:25 | Development of a Large Volume Delivery System with a Customized Injection Profile (Case Study) Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). 13507 - Berlin, Germany 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 Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain March 2-3, 2023. Agle will also host a print release party with . Bethesda, MD 20814 USA 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 15:30 16:30 | P4: Equipment, Technology, and Utilities 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). Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Cancellation requests must be emailed to [emailprotected]. 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. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit All rights reserved. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development 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. In this session, the speakers will provide insight into state-of-the-art approaches for advancing contamination control through comprehensive analytics and trending, strategies for reduced particulate recovery, and advanced cleaning techniques using physics. Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist 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 If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. You must have this confirmation letter to be considered enrolled in a PDA event. 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering All rights reserved. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs Alaska Airlines, Delta and Southwest service this airport. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. 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. The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. 13507 - Berlin, Germany 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Please contact us if you are entiteld to receive a discount. The group rate at all hotels is $199 for single or double occupancy. [emailprotected], 4350 East West Highway, Suite 600 Chuck W. Seipel, Product Specialist, W.L. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. October 18-19, 2022 Palm Springs, CA Booth #606. Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Peter Holst, Co-Founder and CEO, FPrin, LLC. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. These emails are sent by scammers. 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 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. 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 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 . Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. 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. Juan Cheng, Principal Scientist, Merck & Co., Inc. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices PDA 2022 We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. Ontario International airport (ONT) is 70 miles from Hotel. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Statements claiming to offer our attendee lists are fraudulent. Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems Ontario International airport (ONT) is 70 miles from the Convention Center. 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 rate is $249 for single or double occupancy. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products This Conference will focus on the theme to Level Up: Agility in the New Normal! Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Tel: +65 64965504 Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Additional workshops are anticipated for 2023. Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity Jeffrey Givand, PhD, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Director, Device and Combination Product Development, Merck & Co., Inc. Taxi fares from DAL are approximately $20-25 one way, not including tip. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 CUE 2023 will be a celebration of coming together after two years apart. Young Harris, GA. D3:Data Integrity Trends, Patterns, and Insights Michael de la Torre, CEO, Redica Systems. 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. 115 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. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization On-site Parking is 35 USD daily. These emails are sent by scammers. This session will explore various opportunities for making home drug delivery a reality from smart delivery devices for the home setting, enabling primary containers for single use administration to patient training and on-boarding solutions specifically designed for at-home use. Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. 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. 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. Max Fill Volume Evaluation for Pre-filled Syringes PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Cancellation requests must be emailed to [emailprotected]. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series 3 to 4 p.m. Feb. 20. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. A3: Cleanroom Manufacturing: A New Area Across Technology and Processes Learn about opportunities and benefits. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development Anthony C. Bevilacqua, PhD, Principal Scientist, Mettler-Toledo Thornton. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Diego Zurbriggen, Sr. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success 10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics Events | CHDI Foundation
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