pda conference 2022 palm springs

The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations 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. In this session, speakers will share best practices for container integrity important for vaccine distribution and quality by design principles applied in viral product development. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. Palm Springs, CA. Ulrich Kllisch, PhD, Manager Data Integrity, GxP-CC, 11:05 | A Deep Dive into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights 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 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) 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 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. Palm Desert, CA. Compared to it, Palm TX looks much better it was . Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces Phone: +1 (214) 651-1234. 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. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. 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 The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. 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 In and out privileges for hotel guests only. 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. Tel: +49 30 436 55 08-0 or -10 HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity These emails are sent by scammers. PDA will not be responsible for any costs incurred by registrants due to cancellation. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Interested in becoming an exhibitor? To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. 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. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member). 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. Bethesda, MD 20814 USA 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 Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company. All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. 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. Sherri Biondi, PhD, Executive Director, Head of Device Development, AstraZeneca, A3: Bridging the Gap: Advancing from Clinical Development Stages to Commercial Market Supply 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). Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter, 10:45 | Primary Container Sequence for On-body Large Volume Injectors: From Vial to Pre-filled Cartridge PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. David Booth, PE, Senior Consultant, LMI. 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 Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. 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. This conference gives Georgia-based nursing educators an opportunity to come together and learn about issues and trends related to nursing education in their state. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. CUE 2023 will . The 2022 PDA Annual Meeting promises to have something for everyone! With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors [emailprotected], Tel: +1 (301) 656-5900 ext. Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. Tel: +1 (301) 656-5900 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. [emailprotected], 4350 East West Highway, Suite 600 Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. 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. A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes 08:00 09:30 | P1: Overview of and Revision Process for Annex 1 Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R Radish Lot, 8-24 hours | $19 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 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. 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 Mechanically Priming and Controlling Drug Delivery in a Re-usable Auto Injector Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm John Lewin, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals Inc. Palm Springs, CA, 400 East Tahquitz Canyon Way 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. You must have this confirmation letter to be considered enrolled in a PDA event. [emailprotected], Tel: +1 (301) 656-5900 ext. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. An Insight from PFS Manufacturing for AI GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. The 2022 PDA Annex 1 Workshops highlight critical changes in the new regulation and include interactive sessions to provide attendees with a clear understanding of and means to implement all the requirements of the rule. 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! Cancellation requests must be emailed to [emailprotected]. Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Los Angeles International Airport (LAX) is 124 miles from Hotel. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. The group rate is $199 for single or double occupancy. Learn about opportunities and benefits. This session will present impressive opportunities for the future, such as having pharmaceutical products available on demand, and a vision of potential outcomes if companies can move past the concept of wanting to be a fast second to adopting new technologies moving towards a future of going first together! In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. Reservations must be secured by Friday, 04 March 2022. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. ABRF 2020, Palm Springs, California ABRF 2019, San Antonio Texas ABRF 2018, Myrtle Beach, South Carolina ABRF 2017, San Diego, California ABRF 2016, Ft. Lauderdale, Florida ABRF 2015, St. Louis, Missouri . Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! Since the announcement of a public health emergency in January 2020, we are gingerly entering our third year with the hopes of a new normal. Website| Reservations Link. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing). 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 March 2-3, 2023. Mfg. Peter Holst, Co-Founder and CEO, FPrin, LLC. With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. In and out privileges for overnight guests only, operated by PMSI. Metals and mining is in our DNA. Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Ontario International airport (ONT) is 70 miles from the Convention Center. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. Cheryl Stork, Scientist II, Preclinical Translation, Biora Therapeutics. Drug-Device Combination Products (DDCP) Development and Lifecycle Planning 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. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. 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 It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 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. 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 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. Tel: +1 (301) 656-5900 Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. 04 hours | $22 Please contact us if you are entiteld to receive a discount. The challenges of new product introduction and support of existing products require that companies be aware of new developments. 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. Bethesda, MD 20814 USA Check-in time is 16:00; check-out time is 11:00. Peter Gompper, MSc, MBA, Co-founder, Rubitel, An Iterative Process Utilizing Real World Data Collection to Improve Support for Patients with Diabetes Herve Soukiassian, Assoc. She will verify your status and register you. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring 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. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. App based rides are available to/from the airport. Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic May 15-17, 2022. Please contact us if you are entiteld to receive a discount. The group rate at all hotels is $199 for single or double occupancy. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Individuals will be responsible for payment of their own cancellation fees. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Leaders: Roundtable discussion to focus on Mobile Manufacturing Task Force. Learn about opportunities and benefits. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Copyright Parenteral Drug Association. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. 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). By eliminating the need for silicone in both the barrel and . 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. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. There is an enormous amount of data being collected today, but what does it all mean? It's time to come together and celebrate all that is good about being an educator. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022. Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Young Harris, GA. IG5: Packaging Science 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 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product After the event, Agle will sign books and the Modernism Week 2022 commemorative posters he designed, pictured above. Video, photo, and audio recordings are prohibited at all PDA events. George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Consider the possibilities: Overnight Guests |$32 + tax Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG.

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