Solving your drug delivery needs at PDA | Team Consulting Bethesda, MD 20814 USA Young Harris, GA. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Video, photo, and audio recordings are prohibited at all PDA events. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus 3 people interested. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. Reservations must be secured by Friday, 30 September 2022. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing 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. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring IG4: Visual Inspection These emails are sent by scammers. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Palm Springs Symposium on HIV/AIDS - Cancer Research Institute Tom Mayer, MBA, Business Unit Manager, Sonceboz SA The conference must talk about all the children in your household, even if the people there are only . Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. Guestroom rates are subject to State and Local taxes. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Cancellation requests must be emailed to [emailprotected]. Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices 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. 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. 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 Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond William G. Whitford, Life Science Strategic Solutions Leader, DPS Group, 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space 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. Key learnings and best practices in partnering will be openly discussed. Dallas, TX Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. [emailprotected], Tel: +1 (301) 656-5900 ext. 48 hours| $26 [emailprotected], 4350 East West Highway, Suite 600 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. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). PDA Conference 2022 | Recipharm 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA Other discounts cannot be applied. Individuals will be responsible for payment of their own cancellation fees. Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. IG5: Packaging Science In and out privileges for overnight guests only, operated by PMSI. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. IG3: Quality Risk Management and GXP Auditing. Juan Cheng, Principal Scientist, Merck & Co., Inc. There is an enormous amount of data being collected today, but what does it all mean? Consider the possibilities: 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. Herve Soukiassian, Assoc. [emailprotected], 4350 East West Highway, Suite 600 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). Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). 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 (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. 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 In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. 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 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. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices 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. Reservations must be secured by Friday, 04 March 2022. 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. Maggie Reiff, Vice President, Development, ApiJect Corp. At the completion of this conference, attendees will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. 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 Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations Come and visit us in Booth #222 & 224. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study 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. Director Product Development PMO, BD. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 09:00 | Q&A with Additional Panelist Elizabeth Rivera, Technical Services Manager, STERIS All rights reserved. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. Dr. Forster will also elaborate on how to leverage insights derived from other industries. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Website| Reservations Link. Statements claiming to offer our attendee lists are fraudulent. 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. Chuck W. Seipel, Product Specialist, W.L. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium Moderator: Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Mfg. Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. Additional workshops are anticipated for 2023. James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. 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. 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. A Novel Device for Reconstitution and Administration PDA Universe of Pre-Filled Syringes and Injection Devices Conference 13507 - Berlin, Germany Ontario International airport (ONT) is 70 miles from Hotel. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company For more details visit the concerence website . Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Self Parking 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 Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Tel: +1 (301) 656-5900, Am Borsigturm 60 Modernism Week, celebrating Midcentury Modern design, returns to Palm George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. 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. For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022. Using Regulatory Grade CM&S of a Drug Delivery Systems to Accelerate Device Development If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 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. Moderator: Marc Glogovsky, MS, S.M. 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. Copyright Parenteral Drug Association. Palm Springs Convention Center. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Interested in becoming a sponsor? Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia Tel: +65 64965504 Statements claiming to offer our attendee lists are fraudulent. 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. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. 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. PDA Conference October 18th-19th 2022. 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 Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 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 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. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes Max Fill Volume Evaluation for Pre-filled Syringes This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. 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. Please call 214 653 1101 for train information. Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. 115 This opening plenary features keynotes from two senior biopharmaceutical leaders. ABRF Annual Meeting - Association of Biomolecular Resource Facilities 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 Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. Please contact us if you are entiteld to receive a discount. 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. Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes 115 Individuals will be responsible for payment of their own cancellation fees. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. March 2-3, 2023. 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) 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. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. Tel: +49 30 436 55 08-0 or -10 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions 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. What about equipment that can be incorporated into predesigned modular facilities? App based rides are available to/from the airport. Steven R. Kaufman, MBA, Vice President, Drug Delivery Systems, Stevanato Group, 11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study Tel: +1 (301) 656-5900, Am Borsigturm 60 As the development and production of vaccines need to be prepared for the future, participants will also learn how this can be achieved through implementing end-to-end digitization. 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. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. The Art of Filling and Processing a Pre-filled Syringe 10:45 | Strategies for Total Contamination Control in an Aseptic Environment 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. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R PDA's Universe of Pre-filled Syringes and Injection Devices Conference 10:45 | Data Integrity Trends in 2021 Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. Agle will also host a print release party with . The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. Learn about opportunities and benefits. The pandemic experience typified the need to be prepared for serious unanticipated events. 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. This session will focus on auditing in the new normal by providing details on various techniques and technologies for effective use in audits and inspections. Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? 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 Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. Events | CHDI Foundation After this date, reservations can be made on a space-and-rate available basis only. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are co-hosting the PDA Conference again this year. Check-in time is 16:00; check-out time is 11:00. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training
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