The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. 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! Bethesda, MD 20814 USA The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. The rate is $249 for single or double occupancy. Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Other discounts cannot be applied. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices 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). Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 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. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. CG Global Metals & Mining Conference - Canaccord Genuity This Conference will focus on the theme to Level Up: Agility in the New Normal! The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. Palm Springs, CA, 400 East Tahquitz Canyon Way Moderator: Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company, 13:30 | Seven Key Pillars of Successful Connected Injection Device Development PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! 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. 15:00 | Environmental and Process Monitoring Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Reservations must be secured by Friday, 30 September 2022. 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms Palm Springs, CA, 1300 Tahquitz Canyon Way Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Ontario International airport (ONT) is 70 miles from Hotel. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions CG Global Metals & Mining Conference. 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 If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 After two years, the return to normal is still uncertain. PDA 2022 - Nemera If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. 13:00 14:15 | P3: Premises and Barrier Systems Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Juan Cheng, PhD, Principal Scientist, Merck & Co., Inc. 14:10 | Enabling Viscous Delivery: Impact of Needle Technology on AutoInjector in Vivo Injection Performance Metrics Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 We will conclude by reviewing the shared vision from a cross-industry collaboration. D1: Building Back Better: Innovative Options for Audits and Inspections 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. Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. 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. Palm Springs Symposium on HIV/AIDS - Cancer Research Institute 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. Jeanne E. Moldenhauer, MS, Vice President, Excellent Pharma Consulting, B1: Process Intensification: Increasing Yield per Unit March 2-3, 2023. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. PDA will not be responsible for any costs incurred by registrants due to cancellation. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company Subsequently, we will focus on best practices to validate the method using multivariate approach. Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning Leader: Susan M. Dounce, PhD, Director Commercial Technology Development, West Pharmaceutical Services, Inc. Cancellation requests must be emailed to [emailprotected]. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. [emailprotected], 4350 East West Highway, Suite 600 Marc Glogovsky, MS, S.M. Alaska Airlines, Delta and Southwest service this airport. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. [emailprotected], Tel: +1 (301) 656-5900 ext. 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! Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. 16:00 | Structured Data Frameworks to Enable Digital Tech Transfer It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc. 11:05 | Re-Imagine Audit: Bringing GxP Auditing into the Quality 4.0 Paradigm Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Tel: +1 (301) 656-5900, Am Borsigturm 60 Moderator: Mathias Romacker, Executive Advisor,Kymanox. Interested in becoming an exhibitor? The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! Incorporating Sustainability Considerations Within the Device Selection Process Top PFAS Conferences in 2022 | News Direct Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole. Iain Simpson,Commercial Director, Phillips-Medisize. What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R 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. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs Naresh K. Budhavaram, PhD, Senior Consultant Engineer, Eli Lilly and Company, 16:05 | Assessing the Environmental Impact of Global Supply Chain Logistics and Supplier Selection for Injection Devices Please call 214 849 6831 for bus information. IG6: Microbiology/ Environmental Monitoring 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. 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.