Tom Mayer, MBA, Business Unit Manager, Sonceboz SA 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 [emailprotected], 4350 East West Highway, Suite 600 IG4: Visual Inspection Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. 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. Other discounts cannot be applied. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. 3 people interested. 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. Manager, R&D, Product Sustainment, West Pharmaceutical Services, Inc. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Joerg Stumbaum, Project Manager, PPS&P, Vetter 10:15 11:20 | P6: Production Technologies, Part 1 Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products (DCP), Genentech, Inc. Reservations must be secured by Friday, 30 September 2022. 824 hours | $32. Jeffrey Givand, PhD, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Director, Device and Combination Product Development, Merck & Co., Inc. Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Leader: Marc Glogovsky, MS, SM (NRCM), Senior Consultant - Microbiology, ValSource, Inc. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. . Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes Uri Baruch, MEng, Partner & Head of Drug Delivery, Cambridge Design Partnership, B2: Deep Cold Storage: How to Improve Integrity and Stability This is the final workshop in a series that PDA has hosted in 2022 to educate and help the industry implement the new Annex 1 revision. No refunds will be granted for requests postmarked after April 13, 2022. Bethesda, MD 20814 USA 10:45 | Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution: A Best Practice Holistic Science-Based Approach 13:00 | Container Closure Integrity Testing and Finishing Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. Video, photo, and audio recordings are prohibited at all PDA events. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma 15:30 16:30 | P4: Equipment, Technology, and Utilities Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility?