10:45 | Process Intensification of Cell-Based Vaccine Manufacturing We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting Since the announcement of a public health emergency in January 2020, we are gingerly entering our third year with the hopes of a new normal. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Copyright Parenteral Drug Association. Palm Springs, CA, 400 East Tahquitz Canyon Way Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products Jake Keeler, Sr. PDA 2022 - Nemera IG5: Packaging Science [emailprotected], Tel: +49 (0) 30 43 655 08-10 Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The group rate at all hotels is $199 for single or double occupancy. Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc. The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. 08:00 | Welcome Remarks from Workshop Co-Chair 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations The 2022 PDA Annual Meeting promises to have something for everyone! 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. Valet Parking 115 The revised Annex 1 contains a significant amount of new and more detailed content on many topics. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success She will verify your status and register you. The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. App based rides are available to/from the airport. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? PDA Universe of Pre-filled Syringes and Injection Devices Conference 2022 13507 - Berlin, Germany It's time to come together and celebrate all that is good about being an educator. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Stefano Pilati, Technical Evaluation and Product Development Coordinator, Stevanato Group, How to Leverage Your Device Supply Chain and Bring Unique Combination Products and Medical Devices to Market Quicker 08:30 10:00 | P3 Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. 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. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. October 18-19, 2022 Palm Springs, CA Booth #606. PDA Conference 2022 | Recipharm Other discounts cannot be applied. Statements claiming to offer our attendee lists are fraudulent. Moderator: Marc Glogovsky, MS, S.M. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference explores the future of pharmaceutical devices. For more details visit the concerence website . Palm Springs, CA. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop (This applies in particular to costs for submitting documents by courier.). Interested in becoming an exhibitor? March 2-3, 2023. Visit us at booth 113. 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. How was it done, what were the barriers, the learnings, and how could it be done so fast? Lynne Liao, Senior Engineer I, Alexion Pharmaceuticals, 13:50 | Advancements in Fully Robotic No-Touch-Transfer Solutions Used to Introduce RTU Containers into Aseptic Isolators, Enhancing Contamination Control and Sterility Assurance Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Paul Erik Fabricius, Director, Front End Innovation, Phillips-Medisize, 13:50 | Integrating Novel Drug Formulation and Wearable Pump Technologies to Deliver Non-Opioid Moderate to Severe Pain Management Outside of the Clinic It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. With a proven track record of success, our global and diverse team understands the importance of an international, coordinated approach in this highly specialized sector. Leaders: Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market. Please call 214 849 6831 for bus information. Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes Events | CHDI Foundation Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Learn about opportunities and benefits. Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. Type: In-personWhen: May 22-26, 2022Where: Palm Springs, California Conference overview: Battelle's 2022 conference for environmental professionals will cover a range of topics including: Dedicated presentations on PFAS issues Innovations and technologies to address chlorinated and recalcitrant compounds in the environment Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. All costs incurring in connection with visa affairs shall be borne by registrants. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! Tel: +1 (301) 656-5900, Am Borsigturm 60 Tel: +49 30 436 55 08-0 or -10 Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group The focus of this Interest Group will be to discuss different approaches and methodologies to increase our ability to cut down the time it takes to get to market. This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. PDA's Universe of Pre-filled Syringes and Injection Devices Conference, 18-19 October 2022, Palm Springs, CA, Aenovas booth number is 605. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings (This applies in particular to costs for submitting documents by courier.). This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Ugljesa Babic, Junior Project Manager, Schott Schweiz AG. Michael T. Edey, Senior Principal Engineer, Pfizer Inc. 11:05 | Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic 277 N. Avenida Caballeros 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. Reservations must be secured by Friday, 30 September 2022. CUE 2023 will be a celebration of coming together after two years apart. 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. Reservations must be secured by Friday, 04 March 2022. B-Lot, 04 | $7 By eliminating the need for silicone in both the barrel and . Each speaker will introduce us to implementation success stories and encourage a discussion on its application. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. We will highlight whats in store for the future of pharmaceutical manufacturing. After two years, the return to normal is still uncertain. PDA will not be responsible for any costs incurred by registrants due to cancellation. Steven Lynn, MS, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc. 13:45 15:15 | P4: The Future is Bright! 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 Stefan R. Kappeler, PhD, Senior Director Biopharma and Regulatory, Exyte Central Europe GmbH, 11:25 | Quality by Design for Adeno-Associated Virus Products: A Framework The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 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 Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Tel: +65 64965504 No credits will be given for cancellation requests received less than 30 days before the event. You must have this confirmation letter to be considered enrolled in a PDA event. Bethesda, MD 20814 USA Diego Zurbriggen, Sr. Conferences in Palm Springs Category 1 filter applied Conference Clear All DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) DESIRE Leather Weekend June 1st - June 5th, 2023 (10:00am) (Must be Vaxxed) Thu, Jun 1, 6:00 PM Private Hotel - NEW location Palm Springs, CA 57th Annual State Women's Convention Palm Springs, CA, 1300 Tahquitz Canyon Way Interested in becoming a sponsor? Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. [emailprotected], Tel: +1 (301) 656-5900 ext. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. [emailprotected], Tel: +1 (301) 656-5900 ext. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. No refunds will be granted for requests postmarked after April 13, 2022. Elizabeth Rivera, Technical Services Manager, STERIS 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. Moderator: Mathias Romacker, Executive Advisor,Kymanox. The Covid-19 pandemic taught us that if from one side we need to preserve those quality and safety standards, from another we need to create an ecosystem able to react quickly to unforeseen events. Amin Sedighiamiri, PhD, Associate Director, AstraZeneca, 13:50 | Addressing Primary Container Challenges in Autoinjector Drug Delivery: Interim Results of a Multiphase Bioburden Study for a Cartridge-Based Autoinjector 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. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Fax: +65 6496 5599, Manager Registration, Chapters & Membership. Humberto Vega, PhD, Sr. Director - Ext. Jason J. Orloff, ChE, Principal Engineer and Statistician, PharmStat, 11:25 | Continuous Bioprocessing: Regulatory Harmonization and Industry Best Practices Quality and Regulatory Shifts Driving Implementation of Flexible Biopharmaceutical Manufacturing Systems Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. 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. Palm Springs Symposium on HIV/AIDS - Cancer Research Institute 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. Richard M Johnson, MSc, President and CEO, PDA Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems.
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