Discuss market, industry trends and new technologies. If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Interested in becoming an exhibitor? 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. (This applies in particular to costs for submitting documents by courier.). IG2: Process Validation and Lyophilization. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. The aim of this conference is to provide the latest information and to . 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. PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies. Oct 12, 2022. Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! The rate is $249 for single or double occupancy. After this date, reservations can be made on a space-and-rate available basis only. This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing together industry experts to share their experiences, new developments, regulatory considerations, challenges, and industry trends in this exciting area. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. 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. By eliminating the need for silicone in both the barrel and . In and out privileges for hotel guests only. IG4: Visual Inspection Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Please contact us if you are entiteld to receive a discount. 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 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. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 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. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration 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. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Palm Springs International Airport (PSP) is 1.5 miles from Hotel. Marc Glogovsky, MS, S.M. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. Lets discuss advances in the use of AI in automated visual inspection. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 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. This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. Cancellation requests must be emailed to [emailprotected]. 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 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. 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. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities. Managing Software Development for an on Body Delivery System Using FDA Guidance and ISO/IEC Standards 3 to 4 p.m. Feb. 20. Agle will also host a print release party with . Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Indulge in the ultimate relaxation at Renaissance Palm Springs Hotel. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 08:00 | Opening Remarks from Conference Co-Chairs and Awards Presentations Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Ontario International airport (ONT) is 70 miles from Hotel. The successful development and commercialization of combination products requires robust partnerships between pharma, device, and component suppliers. Mfg. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Ludovic Gil, R&D Engineer, BD, Human Factors Approach to Incorporating Connectivity into Medical Device Connectivity It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Bethesda, MD 20814 USA The points-to-consider paper that our team is developing should be published at about this time. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. This Hotel does not offer shuttle service. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. 15:00 | Environmental and Process Monitoring Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Tel: +49 30 436 55 08-0 or -10 Palm Desert, CA. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing.

September 21 Florida Woman, Ford Program 21n08 Pcm Reprogram Due To Engine Shudder, Tommy Lee Jones Health Problems, Texas Newspapers By Circulation, Brands Like Joah Brown, Articles P