pda conference 2022 palm springs

Please call 214 849 6831 for bus information. Tel: +49 30 436 55 08-0 or -10 In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. 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. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. Ontario International airport (ONT) is 70 miles from the Convention Center. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. 04 hours | $22 Dallas, TX Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems Toni Manzano, PhD, CSO and Co-Founder, Aizon. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. Danny Miranda, PhD, Associate Director, Human Factors Engineering, Bristol Myers Squibb, Getting the Most from Life Cycle Assessment in Product Development 13:00 | Container Closure Integrity Testing and Finishing Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms Joerg Stumbaum, Project Manager, PPS&P, Vetter At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization. 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 Important Nursing Education Conferences to Attend in 2023 Tom Mayer, MBA, Business Unit Manager, Sonceboz SA Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes No credits will be given for cancellation requests received less than 30 days before the event. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. A1: Game Plan: Progress to the Next Stage of Contamination Control The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. Drug-Device Combination Products (DDCP) Development and Lifecycle Planning By eliminating the need for silicone in both the barrel and . 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. 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. 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. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. 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 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. How was it done, what were the barriers, the learnings, and how could it be done so fast? Amy Hartl, PhD, Director of Process Development, SHL Medical PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. 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. Max Fill Volume Evaluation for Pre-filled Syringes Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond

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