15:00 | Environmental and Process Monitoring Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone 15:30 16:30 | P4: Equipment, Technology, and Utilities There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. These emails are sent by scammers. 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 On-site Parking is 35 USD daily. We will conclude by reviewing the shared vision from a cross-industry collaboration. Connecting People, Science and Regulation. Valet Parking, operated by PMSI, is available at hotel entrance. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together 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. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes. Dallas, TX A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. 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. Reza Abedian, PhD, Senior Medical Affairs Manager, Gerresheimer, B4: Update on ISO Standards and Regulatory Best Practices With your valuable input, we can determine if there is value in having a deeper discussion (i.e., potential PDA project) around this idea of integrating, coordinating, prefabricating, or even prequalifying critical components of a facility ahead of the construction. Oct 12, 2022. Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. 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 PDA will not be responsible for any costs incurred by registrants due to cancellation. Joe Del Rossi, MS, Director, R&D Labs, West Pharmaceutical Services, Inc. 10:15 11:20 | P6: Production Technologies, Part 1 The Interest Group will be discussing the recently launched a survey on process validation approaches. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Weve come together to create effective tools to fight a global pandemic. 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. Key learnings and best practices in partnering will be openly discussed. 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. Peter Holst, Co-Founder and CEO, FPrin, LLC. You must have this confirmation letter to be considered enrolled in a PDA event. DART Light Rail Service: The hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLCand Co-Chair, 2022 PDA Annual Meeting, 13:30 | Jeffrey C. Baker, PhD, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. By eliminating the need for silicone in both the barrel and . Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and Chair, PDA Board of Directors Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal All rights reserved. This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. 15:00 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring C3: Responding to Patient Needs Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products 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. She will verify your status and register you. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) 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. 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. Tel: +1 (301) 656-5900, Am Borsigturm 60 PDA will not be responsible for any costs incurred by registrants due to cancellation. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Consider the possibilities: B2: New Technologies in Bioprocessing 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. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. All costs incurring in connection with visa affairs shall be borne by registrants. DP and Critical Materials, Bristol-Myers Squibb. 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device Tom Mayer, MBA, Business Unit Manager, Sonceboz SA Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? 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. Ronald Forster, PhD, Executive Director, Amgen, 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall. Peter Nelson, Manager, R&D Verification Lab, West Pharmaceutical Services, Inc. Needle-Tissue Interactions in Relation to Design of Autoinjectors David Booth, PE, Senior Consultant, LMI. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! The revised Annex 1 contains a significant amount of new and more detailed content on many topics. Taxi fares from DFW are approximately $45-50 one way, not including tip. Visit the Gore team in the Exhibit Hall at Booth 608 to learn more about GORE IMPROJECT Plungers. 13:50 | Is the Autoinjector Platform Design Good Enough for Your Project Need? In and out privileges for overnight guests only, operated by PMSI. After this date, reservations can be made on a space-and-rate available basis only. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Learn about opportunities and benefits. The 2023 Palm Springs Symposium on HIV/AIDS " On the Road to HIV Eradication " will be March 23 - 25, 2023 in Palm Springs, CA. Tel: +1 (301) 656-5900 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. 13:00 13:50 | P7: Production Technologies, Part 2 Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. 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 Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. 13:30 | An Improved Product Development Framework for Designing Reliable Auto Injectors Connecting People, Science and Regulation, Gov./Health Authority/Academic (Member/Non-Member), Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision, Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations. Mathias Romacker, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Advisor, Kymanox, 08:30 | The COVID-19 Vaccine Development Story Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Director Product Development PMO, BD. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. 08:30 | The Challenges and Rewards Developing a World-Changing Pharmaceutical Innovative and Disrupted Patient-Focused Solution Learn about opportunities and benefits. 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 10:00 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall. Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GSK, 07:15 | Advancing PFS Unit Level Traceability with RFID The Palm Springs workshop, 20-21 Oct., is the fourth sponsored by PDA in 2022. Overnight Guests |$32 + tax Finally, we will discuss where commonalities exist between antibody therapies and advanced therapies which would allow the substantial packaging knowledge amassed to date to be translated and leveraged in this rapidly changing landscape. Discuss the market benefits of pre-filled syringes and injection devices; Identify critical attributes of end-user friendly devices; Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime; Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices, and final drug/device combo products; Discuss quality standards, regulatory and compliance concerns; List insights through case studies presented by industry experts; and. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. Janmeet Anant, Senior Regulatory Consultant, MilliporeSigma, C1: Vaccine and Virus Products in Focus Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Radish Lot, 04 hours | $9 Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Samuel Dauphinais, MBA, Manager, R&D, Product Engineering, West Pharmaceutical Services, Inc. Compared to it, Palm TX looks much better it was . Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. 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. [emailprotected], Tel: +1 (301) 656-5900 ext. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen. Alex Lyness, PhD, Senior Manager, Research and Technology, West Pharmaceutical Services, Inc. 11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Wendy Woodley, Staff Scientist II, BD. Karen Ginsbury, MSc, Owner, PCI Pharmaceutical Consulting Israel, 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success For more details visit the concerence website . Guestroom rates are subject to State and Local taxes. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Paul Lopolito, Sr. Technical Services Manager, STERIS, B3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration We will highlight what's in store for the future of pharmaceutical manufacturing. This session will discuss the latest developments in industry standardization. A1: Game Plan: Progress to the Next Stage of Contamination Control In this session, the speakers will provide insight into modern microbial methods by discussing the validation process and regulatory acceptance for an automated colony counter utilizing a cross functional industry team, navigating speedbumps throughout implementation of a biofluorescent particle counting system, and a case study on rapid microbial detection for a purified water system. Lee Leichter, RAC, MBA, President, P/L Biomedical. HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Self Parking Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. Join us in Palm Springs for the ultimate educator experience! Andrea Dwyer, MS, CHFP,Associate Research Director - Human Factors Research & Design,Emergo by UL. This Conference will focus on the theme to Level Up: Agility in the New Normal! Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. 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. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. IG1: Biopharmaceutical Manufacturing Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. 18/10/2022 - 19/10/2022 Palm Springs, CA. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! PDA will not be responsible for any costs incurred by registrants due to cancellation. Alaska Airlines, Delta and Southwest service this airport. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. 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. Moderator: Maurice Verschuren, MSc, Device Platform Lead Director, Amgen. Jake Keeler, Sr. 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles The speaker will conclude with a discussion how to apply the lightspeed paradigms for future successes. This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. 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 Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA Tel: +65 64965504 Medical Device Test Method Validation: Practical Strategies for Overcoming Common Challenges with Destructive GageR&R Interested in becoming an exhibitor? 300 Reunion Boulevard Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Other vaccine platforms and manufacturing technologies that have received less attention will also be important in the future to produce vaccines that can be rapidly manufactured at a low cost, with characteristics needed for easy storage and distribution. Other discounts cannot be applied. Rocks offers a trendy bar setting to unwind after a day of exploring the Palm Springs Aerial Tramway, Palm Springs Art Museum and boutique shops along the city's main thoroughfare. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. 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 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms B-Lot, 04 | $7 Copyright Parenteral Drug Association. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Amy Hartl, PhD, Director of Process Development, SHL Medical The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) 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. Moderator: Manfred Maeder, Head Device Dev. Join us for our global Metals and Mining conference bringing together . Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. 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 Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Join Gore at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Please contact us if you are entiteld to receive a discount. Taxi fares from DAL are approximately $20-25 one way, not including tip. Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 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. Individuals will be responsible for payment of their own cancellation fees. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes Bethesda, MD 20814 USA Phone: +1 (214) 651-1234. Xi Zhao, Senior Scientist, Merck & Co., Inc. Finally, we will learn about regulatory considerations. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. Learn about opportunities and benefits. : New Technology Facilitating Process-Product Communication This session will provide insight on critical design principles during the development of a (large volume) autoinjector, including real-time assessments to share important learnings from industry leaders. A refund of the full conference fee, minus a $100 administrative fee, will be given for cancellations received by that date. Reservations must be secured by Friday, 30 September 2022. Open letter to the Secretaries of State for Housing and Justice - 10/10/2022. 13:30 | Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commercial Operations David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond 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 A3: Cleanroom Manufacturing: A New Area Across Technology and Processes 115 (This applies in particular to costs for submitting documents by courier.). 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). Phone: +1 (760) 322-6100 Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination 16:40 | What If Sterile Product Processing Equipment Could Talk? Gore & Associates, Breakfast 2: Device Platforms Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study The group rate is $199 for single or double occupancy.