Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc. 11:05 | Re-Imagine Audit: Bringing GxP Auditing into the Quality 4.0 Paradigm The Palm Springs workshop, 20-21 Oct., is the fourth sponsored by PDA in 2022. Tel: +49 30 436 55 08-0 or -10 The Art of Filling and Processing a Pre-filled Syringe Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors 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 10:45 | Strategies for Total Contamination Control in an Aseptic Environment 08:00 | Welcome Remarks from Workshop Co-Chair 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. Learn about opportunities and benefits. 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Richard M Johnson, MSc, President and CEO, PDA Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 09:00 | Q&A with Additional Panelist Each speaker will introduce us to implementation success stories and encourage a discussion on its application. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Interested in becoming a sponsor? Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. Palm Springs, CA, 1300 Tahquitz Canyon Way The 2022 PDA Annual Meeting promises to have something for everyone! This session opens our in-depth look at the content of the draft Annex 1. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 15:45 | Hybrid Prefilled Syringes Suitable for Cold Storage Vaccines and Biologic Drugs Without Compromising Container Closure Integrity Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success 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 The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. Cancellation requests must be emailed to [emailprotected]. Michael T. Edey, Senior Principal Engineer, Pfizer Inc. 11:05 | Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic Incorporating Sustainability Considerations Within the Device Selection Process (This applies in particular to costs for submitting documents by courier.). 15:00 | Environmental and Process Monitoring Peter Holst, Co-Founder and CEO, FPrin, LLC. 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 Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. A1: Game Plan: Progress to the Next Stage of Contamination Control B-Lot, 48 hours | $13 October 18, 2022 - October 19, 2022. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development IG4: Visual Inspection Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. IG2: Process Validation and Lyophilization. Iain Simpson,Commercial Director, Phillips-Medisize. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization 115 James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. 10:15 11:20 | P6: Production Technologies, Part 1 Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC, 16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. By eliminating the need for silicone in both the barrel and . Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Join us in Palm Springs for the ultimate educator experience! Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. (This applies in particular to costs for submitting documents by courier.). We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. 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 15:15 16:00 | Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall, A2 D3:Data Integrity Trends, Patterns, and Insights Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . All costs incurring in connection with visa affairs shall be borne by registrants. These emails are sent by scammers. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). [emailprotected], Tel: +1 (301) 656-5900 ext. 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 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment Finally, we will discuss where commonalities exist between antibody therapies and advanced therapies which would allow the substantial packaging knowledge amassed to date to be translated and leveraged in this rapidly changing landscape. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. The aim of this conference is to provide the latest information and to . This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. . Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Moderator: Alessandro Morandotti, Head of the Technical Account Management, Stevanato Group, 13:30 | Development of New Reusable Autoinjector for Automated Reconstitution and Injection of Drug from a Disposable Dual Chamber Cartridge Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. 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. Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage 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 Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Tel: +65 64965504 Consider the possibilities: John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Radish Lot, 04 hours | $9 No credits will be given for cancellation requests received less than 30 days before the event. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings 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 Humberto Vega, PhD, Sr. Director - Ext. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company 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. Mfg. Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. 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. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. 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. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 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 She will verify your status and register you. 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. We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. 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. Estimated Taxi Fare 7 USD (one way). Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Interested in becoming a sponsor? 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi, 15:55 | Q&A and Final Discussion with Additioanl Panelists The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. 115 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. Join us for our global Metals and Mining conference bringing together . Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. 3 people interested. Self Parking A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics Palm Springs, CA, 400 East Tahquitz Canyon Way 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. Bethesda, MD 20814 USA The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA 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 In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform 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. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems IG5: Packaging Science Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting (This applies in particular to costs for submitting documents by courier.). This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1. All rights reserved. 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) 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. Taxi fares from DAL are approximately $20-25 one way, not including tip. The new Annex 1 revision was recently released! Joerg Stumbaum, Project Manager, PPS&P, Vetter Ontario International airport (ONT) is 70 miles from the Convention Center. These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. This session will discuss the latest developments in industry standardization. This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. After this date, reservations can be made on a space-and-rate available basis only. 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. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. Diego Zurbriggen, Sr. B2: New Technologies in Bioprocessing PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. DART Light Rail Service: The hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Subsequently, we will focus on best practices to validate the method using multivariate approach. 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference Oct 18 - Oct 19, 2022 Palm Springs, CA The New Normal in Injectable Drug Delivery Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The agenda is available! Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. 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. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! Compared to it, Palm TX looks much better it was . 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 Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. 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. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop Ron Pettis, Director, Translational and Clinical Sciences, BD, 15:00 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall, 15:45 17:30 | P4: Investing in the Future Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. 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. Thomas James, Mechanical Engineer, Key Tech Phone: +1 (888) 236-2427. Learn about opportunities and benefits. Bethesda, MD 20814 USA decide if a child protection plan should be drawn up for your child. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Director Product Development PMO, BD. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. 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. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Regulatory Perspective This session will expand on the regulatory challenges we have endured and how we anticipate the future. uber drop off at contemporary resort, i want to withdraw my asylum application, spectrum affinity drug testing,
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