pda conference 2022 palm springs

Join us for our global Metals and Mining conference bringing together . If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 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. 10:15 11:20 | P6: Production Technologies, Part 1 Statements claiming to offer our attendee lists are fraudulent. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit IG8: Facilities and Engineering Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage Cancellation requests must be emailed to [emailprotected]. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. 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 : New Technology Facilitating Process-Product Communication Subsequently, we will focus on best practices to validate the method using multivariate approach. Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? These emails are sent by scammers. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. 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. James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. 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. 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 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! The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity 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. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission 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 This opening plenary features keynotes from two senior biopharmaceutical leaders. 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. October 18, 2022 - October 19, 2022. 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 [emailprotected], Tel: +49 (0) 30 43 655 08-10 Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. [emailprotected], Tel: +1 (301) 656-5900 ext. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Ugljesa Babic, Junior Project Manager, Schott Schweiz AG. Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Guestroom rates are subject to State and Local taxes. Phone: +1 (214) 651-1234. 15:30 | Water Systems and Other Critical Utilities 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. 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. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. She will verify your status and register you. Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist 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 Tom Mayer, MBA, Business Unit Manager, Sonceboz SA 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 Anne-Sofie Staples, MSc, Industrial PhD Student, University of Copenhagen/Novo Nordisk A/S B-Lot, 04 | $7 IG6: Microbiology/ Environmental Monitoring 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. Tel: +1 (301) 656-5900, Am Borsigturm 60 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. 2022 PDA Annex 1 Workshop (Palm Springs) Oct 20 - Oct 21, 2022 Palm Springs, CA Closed Overview Agenda Speakers Additional Information Travel Registration Fees Exhibit & Sponsorship Related Events Contact Program Highlights The new Annex 1 revision was recently released! The 2022 PDA Annual Meeting promises to have something for everyone! 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. 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. PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company 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. Peter Holst, Co-Founder and CEO, FPrin, LLC. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Tel: +65 64965504 115 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. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. 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). Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Ontario International airport (ONT) is 70 miles from Hotel. Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma What about equipment that can be incorporated into predesigned modular facilities? Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 13507 - Berlin, Germany Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities 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 Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. In and out privileges for overnight guests only, operated by PMSI. The pandemic experience typified the need to be prepared for serious unanticipated events. 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. BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA The challenges of new product introduction and support of existing products require that companies be aware of new developments. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. 10:15 | Aseptic Processing IG1: Biopharmaceutical Manufacturing Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals. Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA IG5: Packaging Science HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. No credits will be given for cancellation requests received less than 30 days before the event. 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. A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products 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. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies (NRCM), Senior Consultant Microbiology, ValSource Inc. Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. You must have this confirmation letter to be considered enrolled in a PDA event. Copyright Parenteral Drug Association. 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. [emailprotected], Tel: +1 (301) 656-5900 ext. 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. Interested in becoming an exhibitor? 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product [emailprotected], 4350 East West Highway, Suite 600 To progress our organizations to the next level, new and innovative ways of thinking need to be employed. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training Please contact us if you are entiteld to receive a discount. 15:00 | Environmental and Process Monitoring Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. This session will expand on the regulatory challenges we have endured and how we anticipate the future. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. All rights reserved. Get in touch with Aenova and contact us here ! 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 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 Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy You must have this confirmation letter to be considered enrolled in a PDA event. 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. Toni Manzano, PhD, CSO and Co-Founder, Aizon. 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. 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. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization The rate is $249 for single or double occupancy. Reservations must be secured by Friday, 04 March 2022. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . Learn about opportunities and benefits. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Please call 214 653 1101 for train information. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! John D. Ludwig, PhD, Senior Vice President, Medicinal Sciences, Pfizer, 09:00 | Combination Product and Device Platform Approach 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. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. 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. The points-to-consider paper that our team is developing should be published at about this time. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Elizabeth Rivera, Technical Services Manager, STERIS 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Palm Springs Convention Center. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Palm Springs, CA, 1300 Tahquitz Canyon Way The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. How was it done, what were the barriers, the learnings, and how could it be done so fast? 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone The group rate at all hotels is $199 for single or double occupancy. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy. Mfg. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. C3: Responding to Patient Needs 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. Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces We will conclude by reviewing the shared vision from a cross-industry collaboration. 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs (This applies in particular to costs for submitting documents by courier.). If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. In this session, attendees will hear insights and analyses from three experts who have reviewed industry data trends in the areas of data integrity, regulatory observations, and recalls. 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. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Consider the possibilities: It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. A1: Game Plan: Progress to the Next Stage of Contamination Control Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? No credits will be given for cancellation requests received less than 30 days before the event. Xi Zhao, Senior Scientist, Merck & Co., Inc. CUE 2023 will . In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Nitin Rathore, PhD, Executive Director, Amgen Inc. 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies Humberto Vega, PhD, Sr. Director - Ext. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities 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. Other discounts cannot be applied. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Bethesda, MD 20814 USA The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Find your oasis while lounging beside one of the area's largest outdoor pools or sipping a refreshing drink in one of our private cabanas. $18. Collaboration and Commitment Can Lead to Awe-Inspiring Results B2: New Technologies in Bioprocessing 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. 15:30 16:30 | P4: Equipment, Technology, and Utilities DP and Critical Materials, Bristol-Myers Squibb. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. 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. Radish Lot, 04 hours | $9 Bethesda, MD 20814 USA Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Lee Leichter, RAC, MBA, President, P/L Biomedical. Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. In this Interest Group Meeting, participants will discuss PDA Technical Report No. Join us in Palm Springs for the ultimate educator experience! Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices decide how to keep your child safe. Bethesda, MD 20814 USA Dr. Forster will also elaborate on how to leverage insights derived from other industries. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 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. A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies
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