Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes. and Commercialization, Device Dev/Commercialization, Novartis International AG, 13:30 | Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Product Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations 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. 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 Interested in becoming an exhibitor? 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. 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. Copyright Parenteral Drug Association. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. Peter Holst, Co-Founder and CEO, FPrin, LLC. Paul Erik Fabricius, Director, Front End Innovation, Phillips-Medisize, 13:50 | Integrating Novel Drug Formulation and Wearable Pump Technologies to Deliver Non-Opioid Moderate to Severe Pain Management Outside of the Clinic Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. 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. 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. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia 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. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. These emails are sent by scammers. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. 15:30 16:30 | P4: Equipment, Technology, and Utilities The purpose of a child protection conference is to: share information between all the professionals who are working with your family. 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. Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. 13507 - Berlin, Germany If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 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. Interested in becoming a sponsor? 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. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Come and visit us in Booth #222 & 224. Overnight Guests |$32 + tax Palm Springs, CA, 400 East Tahquitz Canyon Way Ontario International airport (ONT) is 70 miles from the Convention Center. Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy Bethesda, MD 20814 USA The conference must talk about all the children in your household, even if the people there are only . 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Radish Lot, 8-24 hours | $19 Palm Springs, CA. The challenges of new product introduction and support of existing products require that companies be aware of new developments. 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. This session will expand on the regulatory challenges we have endured and how we anticipate the future. George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles In and out privileges for hotel guests only. Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Tel: +65 64965504 This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring A Novel Device for Reconstitution and Administration We will conclude by reviewing the shared vision from a cross-industry collaboration. Finally, we will learn about regulatory considerations. 3 to 4 p.m. Feb. 20. : New Technology Facilitating Process-Product Communication The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Amy Hartl, PhD, Director of Process Development, SHL Medical Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. 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. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Amy Hartl, PhD, Director of Process Development, SHL Medical Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Tel: +1 (301) 656-5900 Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards Lee Leichter, RAC, MBA, President, P/L Biomedical. Open letter to the Secretaries of State for Housing and Justice - 10/10/2022. 13:55 | Donna Boyce, MS, Senior Vice President Global Regulatory Affairs, Pfizer Inc. 15:30 17:00 | 15:30 17:00 | P2: Facing the Future 48 hours| $26 An Insight from PFS Manufacturing for AI Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Cancellation requests must be emailed to [emailprotected]. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. How was it done, what were the barriers, the learnings, and how could it be done so fast? John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Young Harris, GA. 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 Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems. Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. 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 With the steep rise of biotherapeutic drugs comes an ongoing trend towards silicone-free container closure systems for sensitive biotech drugs. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. 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. 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. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. 13:00 14:15 | P3: Premises and Barrier Systems 08:00 | Welcome Remarks from Workshop Co-Chair Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. May 15-17, 2022. 3 people interested. All rights reserved. Other discounts cannot be applied. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). For more details visit the concerence website . This session will discuss the latest developments in industry standardization. 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing 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 The session will include a discussion on the key opportunities and challenges ahead, as well as how biopharma representatives should evaluate investment options in this future changing market. The New Normal in Injectable Drug Delivery. Sheldon Moberg, MA, SVP Drug Delivery, Bexson Biomedical, 14:10 | A Patient-Centered Approach to Development of Novel On-Body Drug-Delivery Solutions for Injectable Biologics: A Study with Multiple Target Groups Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA 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). This will be followed by Amgens Dr. Ronald Forster discussing the merits of developing platform technologies, and how they enable continuous improvement in the patient journey through product quality, innovation, and manufacturing efficiency. Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. IG5: Packaging Science Statements claiming to offer our attendee lists are fraudulent. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Moderator: Marc Glogovsky, MS, S.M. 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.
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