Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability Interested in becoming a sponsor? Bethesda, MD 20814 USA Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED). Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company PDA 2022 | Cambridge Pharma Modernism Week, celebrating Midcentury Modern design, returns to Palm Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Esther Foo, PhD, Senior Scientist, Merck & Co., Inc. 11:25 |Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products All rights reserved. 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. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. 15:30 16:30 | P4: Equipment, Technology, and Utilities Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. Kentucky League of Nursing Annual Nurse Educator Conference and Meeting. 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. This Conference will focus on the theme to Level Up: Agility in the New Normal! Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. All rights reserved. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. 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. Key learnings and best practices in partnering will be openly discussed. 2022 PDA Universe of pre-filled Syringes and Injection Devices The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Please call 214 653 1101 for train information. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Tel: +1 (301) 656-5900, Am Borsigturm 60 In the first presentation, Dr. John Ludwig will take the audience through Pfizers amazing journey in developing the COVID-19 vaccine. An Insight from PFS Manufacturing for AI Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. The group rate at all hotels is $199 for single or double occupancy. Moderator: Theresa E. Bankston, PhD, VP Customer Success, BD, 15:45 | Digital Healthcare in Drug Delivery: The Pillars of Hardware and Software to Empower the End User It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. 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. Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 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. PDA will not be responsible for any costs incurred by registrants due to cancellation. Self Parking If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG, 07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination This opening plenary features keynotes from two senior biopharmaceutical leaders. 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event. (This applies in particular to costs for submitting documents by courier.). Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? 04 hours | $22 Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study 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. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group), Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System