Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. Ypsomed is presenting a brand . The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) 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 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. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. 300 Reunion Boulevard Dallas, TX Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. She will verify your status and register you. Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc. Dean Minnock, PhD, CEO, Innovation Zed, 16:05 | Evidence-Led Development of Digital Health Solutions Aimed to Improve Patient Engagement Palm Desert, CA. The safety and wellbeing of our participants is a top priority for PDA; therefore, we will be implementing the following guidelines for this in-person event: Participants, including attendees, exhibitors, trainers, students, staff, guests, contractors, and vendors, must provide proof of vaccination after registering for an in-person event. Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. All costs incurring in connection with visa affairs shall be borne by registrants. Jake Keeler, Sr. Accommodation may be offered on a case-by-case basis for any in-person participant who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice, unless otherwise provided under applicable state or local law. In and out privileges for overnight guests only, operated by PMSI. Moderator: Alessandro Morandotti, Head of the Technical Account Management, Stevanato Group, 13:30 | Development of New Reusable Autoinjector for Automated Reconstitution and Injection of Drug from a Disposable Dual Chamber Cartridge She will verify your status and register you. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies This Hotel does not offer shuttle service. Fax: +65 6496 5599, Manager Registration, Chapters & Membership. Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs The session will include a discussion on the key opportunities and challenges ahead, as well as how biopharma representatives should evaluate investment options in this future changing market. Paolo Golfetto, Drug Delivery Systems Business Development Director, Stevanato Group Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing 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. 13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together This session will expand on the regulatory challenges we have endured and how we anticipate the future. The Art of Filling and Processing a Pre-filled Syringe Marc Glogovsky, MS, S.M. The New Normal in Injectable Drug Delivery. 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. These emails are sent by scammers. 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 George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! 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 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 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. 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. 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles 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 Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Visit us at booth 113. 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company. Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. IG2: Process Validation and Lyophilization. This conference gives Georgia-based nursing educators an opportunity to come together and learn about issues and trends related to nursing education in their state. Statements claiming to offer our attendee lists are fraudulent. [emailprotected], Tel: +1 (301) 656-5900 ext. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC, 16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. Discuss market, industry trends and new technologies. Max Fill Volume Evaluation for Pre-filled Syringes Los Angeles International Airport (LAX) is 124 miles from the Convention Center. Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH. Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain 10:15 11:20 | P6: Production Technologies, Part 1 The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. Innovative Methodologies to Accelerate the Development of Combination Products for Novel Drug Products Involving Delivery of High Dose High Viscosity Formulations Patrick Grandt, Medical Device Engineer, Genentech, Inc. A Packaging Platform for Pre-Filled Syringes and Self-Injection Devices; How Unit-Level Compliance Can Improve Treatment Outcomes Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products Other discounts cannot be applied. Sheldon Moberg, MA, SVP Drug Delivery, Bexson Biomedical, 14:10 | A Patient-Centered Approach to Development of Novel On-Body Drug-Delivery Solutions for Injectable Biologics: A Study with Multiple Target Groups Copyright Parenteral Drug Association. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Stephanie G. Horn, PhD, Technical Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd. C4: Autoinjectors: Development for Success Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission 13507 - Berlin, Germany Video, photo, and audio recordings are prohibited at all PDA events. 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. Leaders: This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Current global issues like supply chain issues and drug shortages unfortunately wont come to an end tomorrow. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes Metals and mining is in our DNA. 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product On-site Parking is 35 USD daily. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. 15:30 16:30 | P4: Equipment, Technology, and Utilities 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization Cambridge, MA June 09, 2022-June 11, 2022 HDSA 37th Annual Convention . Mark Zimmerman, MBA, Business Development, Kimball Electronics, How to Study and Characterize the Container Closure Integrity of Glass Prefilled Syringes During Deep-Cold Storage Cycles Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies. [emailprotected], 4350 East West Highway, Suite 600 Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! Open letter to the Secretaries of State for Housing and Justice - 10/10/2022. Phone: +1 (214) 651-1234. Phone: +1 (760) 322-6100 Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices This session will discuss the latest developments in industry standardization. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs Bethesda, MD 20814 USA Compared to it, Palm TX looks much better it was . PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry. decide how to keep your child safe. Nils Berg Madsen, PhD, Director Device Development, Ascendis Pharma Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes 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 Agility in development and supply chain builds on good clinical and commercial process design and realization. The challenges of new product introduction and support of existing products require that companies be aware of new developments. Please call 214 653 1101 for train information. 3 people interested. Please contact us if you are entiteld to receive a discount. IG5: Packaging Science Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 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. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. 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! With the rise of therapies moving from clinic to home administration, many challenges exist to make this common practice. Parking at the Convention Center costs $10 daily. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. 10:45 | Process Intensification of Cell-Based Vaccine Manufacturing Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. Iain Simpson,Commercial Director, Phillips-Medisize. All rights reserved. The biopharmaceutical industry has evolved from traditional vaccines and therapeutic proteins to encompass a broad range of modalities, including mRNAs, cell therapies, and other advanced therapeutic medicinal products. Amy Hartl, PhD, Director of Process Development, SHL Medical This opening plenary features keynotes from two senior biopharmaceutical leaders. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes David Booth, PE, Senior Consultant, LMI. 16:40 | What If Sterile Product Processing Equipment Could Talk? Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) 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 Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. 15:00 | Environmental and Process Monitoring The 2022 PDA Annual Meeting promises to have something for everyone! This is the twenty-ninth of an annual series of conferences organized by the UCI Cancer Research Institute and the UCLA CFAR/AIDS Institute. A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG Guestroom rates are subject to State and Local taxes. Palm Springs, CA. Palm Springs Convention Center. Please contact us if you are entiteld to receive a discount. Moderator: Mirko Gabriele, PhD, Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific. (This applies in particular to costs for submitting documents by courier.). The rate is $249 for single or double occupancy. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. 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. Arjun Manoj, Bio-Medical Engineer, Portal Instruments, Ensuring Patients Centricity When Migrating Care from Clinical to Home Settings Continued advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety, 10:00 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. Mfg. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting Estimated Taxi Fare 7 USD (one way). March 2-3, 2023. The purpose of a child protection conference is to: share information between all the professionals who are working with your family. Taxi fares from DAL are approximately $20-25 one way, not including tip. Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C The 2022 PDA Annual Meeting promises to have something for everyone! 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Collaboration and Commitment Can Lead to Awe-Inspiring Results Learn about opportunities and benefits. 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing Fax: +65 6496 5599, PTI - Packaging Tachnologies & Inspection, Manager Registration, Chapters & Membership. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) 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.
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