PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! Greyhound: The nearest Greyhound station is located at 205 S Lamar St. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. 3 people interested. Mark Tunkel, Global Category Director - Services, Nemera, Evaluation of Syringe Plunger Functional Performance to Secure PFS and Auto-injector Integration and Machinability on Filling Lines: Case Study with PremiumCoat 1-3mL Syringe Plunger : New Technology Facilitating Process-Product Communication Tel: +65 64965504 Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. 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. 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. 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. 2022 PDA Annex 1 Workshop: Palm Springs Oct 20 - Oct 21, 2022 Frederic B. Ayers 2022 annex 1 palm springs presenter Eli Lilly and Company Fred was a student-athlete at Franklin College of Indiana and participated in the college's Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Palm Springs Convention Center. George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Los Angeles International Airport (LAX) is 124 miles from Hotel. 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 This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes. This session will offer insights in flexible automation solutions plus a case study on sustainability aspects of a reusable cartridge-based pen injector. Bethesda, MD 20814 USA 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 Copyright Parenteral Drug Association. There is an enormous amount of data being collected today, but what does it all mean? Interested in becoming a sponsor? 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 For more details visit the concerence website . If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. Taking place in Palm Springs, CA, the Conference will dive into interactive sessions and multiple tracks that will address innovation and regulatory trends in the universe of application device technology and explore what's next for the future of this field. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. After this date, reservations can be made on a space-and-rate available basis only. PDA 2022 | Cambridge Pharma It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. In and out privileges for overnight guests only, operated by PMSI. Process intensification involves practices that improve product yield per unit, where unit could be time, consumables, resources, or footprint. Patrick Poisson,EVP, Technical Operations, United Therapeutics Corp. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization). [emailprotected], Tel: +49 (0) 30 43 655 08-10 Fax: +65 6496 5599, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Manager Registration, Chapters & Membership. Isobel Filipova, Design Engineer - Sustainable Product Development, Owen Mumford, How to Ensure Syringe-Autoinjector Compatibility? For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Fax: +65 6496 5599, Manager Registration, Chapters & Membership. The New Normal in Injectable Drug Delivery. Lee Leichter, RAC, MBA, President, P/L Biomedical. Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products After this date, reservations can be made on a space-and-rate available basis only. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. 10:15 | Aseptic Processing Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission Keep an eye out for John Burke, Chris Hurlstone, Alastair Willoughby and Andy Fry to find out how Team Consulting could support your next parenteral device development. Bethesda, MD 20814 USA Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. 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! This opening plenary features keynotes from two senior biopharmaceutical leaders. Thomas James, Mechanical Engineer, Key Tech 15:45 | Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, 16:05 | James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC, The following posters will be presented during each break in the Exhibit Hall. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability 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. Learn about opportunities and benefits. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Events | CHDI Foundation Radish Lot, 8-24 hours | $19 Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Individuals will be responsible for payment of their own cancellation fees. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring Chuck W. Seipel, Product Specialist, W.L. Interested in becoming an exhibitor? Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System Mfg. A1: Game Plan: Progress to the Next Stage of Contamination Control This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. [emailprotected], 4350 East West Highway, Suite 600 Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Using Regulatory Grade CM&S of a Drug Delivery Systems to Accelerate Device Development 08:30 10:00 | P3 Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success Ontario International airport (ONT) is 70 miles from the Convention Center. Palm Springs, CA, 400 East Tahquitz Canyon Way 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 In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Phone: +1 (888) 236-2427. Tel: +49 30 436 55 08-0 or -10 If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Palm Springs, CA November 08, 2021-November 11, 2021 Society for Neuroscience (SfN) A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. Pratik A. Mishra, MEng, Senior Systems Engineer, West Pharmaceutical Services, Inc. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. PDA Universe of Pre-Filled Syringes and Injection Devices Conference housing law practitioners association | For those practicing housing law. Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 10:15 11:20 | P6: Production Technologies, Part 1 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 Rudolf Michael Weiss, Dipl.-Ing., Global Head of Pharma+Medical, Stubli, 07:35 | A Real-World Example of Sustainable Drug Delivery the Development of the First Reusable Pen Injector for Concentrated Insulin Discuss market, industry trends and new technologies. Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. Peter Gompper, MSc, MBA, Co-founder, Rubitel, An Iterative Process Utilizing Real World Data Collection to Improve Support for Patients with Diabetes October 18-19, 2022 Palm Springs, CA Booth #606. Ron Pettis, Director, Translational and Clinical Sciences, BD, 15:00 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall, 15:45 17:30 | P4: Investing in the Future Pharmaceutical Formulation and Process Development, Quality Engineers, Quality Professionals, Regulatory and Compliance Professionals. The agenda is available! 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! Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? Collaboration and Commitment Can Lead to Awe-Inspiring Results Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. 115 What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? We will be attending the PDA - Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, Palm Springs, CA. We will highlight what's in store for the future of pharmaceutical manufacturing. Modernism Week, celebrating Midcentury Modern design, returns to Palm Gore & Associates, Breakfast 2: Device Platforms This airport is serviced by numerous carriers. 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. 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: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Herve Soukiassian, Assoc. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. Tel: +1 (301) 656-5900, Am Borsigturm 60 Reservations must be secured byFriday, 23 September 2022. These emails are sent by scammers. Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. ABRF 2020, Palm Springs, California ABRF 2019, San Antonio Texas ABRF 2018, Myrtle Beach, South Carolina ABRF 2017, San Diego, California ABRF 2016, Ft. Lauderdale, Florida ABRF 2015, St. Louis, Missouri This Conference will focus on the theme to Level Up: Agility in the New Normal! Alaska Airlines, Delta and Southwest service this airport. Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Taxi fares from DFW are approximately $45-50 one way, not including tip. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. 13:30 | An Overview of International Standards Impacting Delivery Devices, ISO TC84, and Recent Changes to ISO 11608 Series Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study 13:55 | Donna Boyce, MS, Senior Vice President Global Regulatory Affairs, Pfizer Inc. 15:30 17:00 | 15:30 17:00 | P2: Facing the Future If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. The first speaker will provide experimental results obtained from comparing both glass and polymer silicone-free container closure systems in terms of functional performance and drug stability. It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Top PFAS Conferences in 2022 | News Direct ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) Michael de la Torre, CEO, Redica Systems. Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting [emailprotected], Tel: +1 (301) 656-5900 ext. 13:00 13:50 | P7: Production Technologies, Part 2 Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH, C2: Transforming Product and Process Knowledge Acquisition to Become More Agile This Conference will focus on the theme to Level Up: Agility in the New Normal! Interested in becoming an exhibitor? Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. 08:00 | Welcome Remarks from Workshop Co-Chair Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. 2022 PDA Annex 1 Workshop (Palm Springs)
