pda conference 2022 palm springs

2022 PDA Universe of pre-filled Syringes and Injection Devices Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. There is an enormous amount of data being collected today, but what does it all mean? Elizabeth Moroney, Principal Scientist, Bristol Myers Squibb. This session will focus on auditing in the new normal by providing details on various techniques and technologies for effective use in audits and inspections. No credits will be given for cancellation requests received less than 30 days before the event. Palm Springs Convention Center. DP and Critical Materials, Bristol-Myers Squibb. (This applies in particular to costs for submitting documents by courier.). PDA Universe of Pre-Filled Syringes and Injection Devices Conference Regulatory agencies have released new policies, flexibilities in procedures, and updates to guidances on the fly, but what are the lasting impact of these changes on our "new normal?. IG8: Facilities and Engineering Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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. Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. 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. 115 Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Modernism Week, celebrating Midcentury Modern design, returns to Palm Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. Tel: +1 (301) 656-5900, Am Borsigturm 60 Moderator: Kakolie G. Banerjee, PhD, Senior Scientist, MilliporeSigma. 15:00 | Environmental and Process Monitoring 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 Gabriele Rustici Venturini, MSc, R&D Engineer - Mechanical Designer, IMA Life, 14:10 | Selecting and Collaborating with Manufacturing Partners to Achieve Successful Product Launch Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. By eliminating the need for silicone in both the barrel and . Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities 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. Cancellation requests must be emailed to [emailprotected]. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Palm Springs, CA, 400 East Tahquitz Canyon Way The 2022 PDA Annual Meeting promises to have something for everyone! 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. 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). PDA Announces Nearly 100 Exhibitors at the 19th Universe of Pre-Filled William G. Whitford, Life Science Strategic Solutions Leader, DPS Group, 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space Interested in becoming a sponsor? 11:05 | Streamlining Human Factors Assessment Strategies for Prefilled Syringes Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes 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 Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics Aidan J. Harrington, PhD, Principal Consultant, DPS Group, 16:40 | Technology Roadmap Phorum Industry Vision 2.0 Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA. Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments Tel: +65 64965504 Please call 214 653 1101 for train information. Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC. Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals Amy Hartl, PhD, Director of Process Development, SHL Medical 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. 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. 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. 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. 13507 - Berlin, Germany Bethesda, MD 20814 USA A Novel Device for Reconstitution and Administration No credits will be given for cancellation requests received less than 30 days before the event. 08:30 10:00 | P3 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. Individuals will be responsible for payment of their own cancellation fees. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities. 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. 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 Interested in becoming a sponsor? 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. 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. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. Cancellation Policy: All registration cancellations and refund requests must be made in writing by April 13,2022. The Interest Group will be discussing the recently launched a survey on process validation approaches. Xi Zhao, Senior Scientist, Merck & Co., Inc. 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 Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic D1: Building Back Better: Innovative Options for Audits and Inspections 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. 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 Spencer Pratt, Software Compliance and Test Manager, West Pharmaceutical Services, Inc. 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. Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. 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. Yik Kit (Grace) Kwok, MBA, Principal Scientist, Merck & Co., Inc. 11:05 | Optimization of Design Transfer and Commercial Scale-Up: An Autoinjector Case Study PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole. Weve come together to create effective tools to fight a global pandemic. [emailprotected], 4350 East West Highway, Suite 600 Individuals will be responsible for payment of their own cancellation fees. Radish Lot, 48 hours | $13 Technological evolution and introduction of novel technologies are required to meet these patient needs. IG2: Process Validation and Lyophilization. Tel: +1 (301) 656-5900, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914 Akshay R. Kamdar, PhD, Senior Director - Container Closure, Materials Engineering and Process Innovation, Eli Lilly and Company 10:15 11:20 | P6: Production Technologies, Part 1 decide how to keep your child safe. Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Karl J. Saldanha, PhD,Regulatory Program Director,Genentech, Inc. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development Ugljesa Babic, Junior Project Manager, Schott Schweiz AG.

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