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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. 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 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. Statements claiming to offer our attendee lists are fraudulent. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist 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. After this date, reservations can be made on a space-and-rate available basis only. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings 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. 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. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Tel: +65 64965504 Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting 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. Donna Gulbinski, Chief Quality and Regulatory Affairs Officer, Civica. The 2022 PDA Annual Meeting promises to have something for everyone! HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. 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. Interested in becoming a sponsor? 13:00 | Container Closure Integrity Testing and Finishing 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 Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference explores the future of pharmaceutical devices. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Dallas, TX