14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) We will conclude by reviewing the shared vision from a cross-industry collaboration. Subsequently, we will focus on best practices to validate the method using multivariate approach. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 decide if a child protection plan should be drawn up for your child. Asmita Khanolkar, MS, Senior Director, Cambridge Pharma, Oval, SMC, Integration of New Technologies with Existing Systems Challenges and Opportunities Importance of 2.25ml Autoinjector Rod to Plunger Design Space an Overlooked Critical Input for Dose Accuracy and Elimination of Leakage If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. The presenters in this plenary session will speak to the challenges and successes from all vantage points in the partnership. Tel: +49 30 436 55 08-0 or -10 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. Individuals will be responsible for payment of their own cancellation fees. Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals, 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces 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. 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. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. 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. 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. The 2022 PDA Annual Meeting promises to have something for everyone! Tel: +1 (301) 656-5900, Am Borsigturm 60 Learn about opportunities and benefits. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. 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. Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower | $19 Phone: +1 (760) 322-6100 Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing Join us for our global Metals and Mining conference bringing together . Interested in becoming an exhibitor? 10:45 |Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone No refunds will be granted for requests postmarked after April 13, 2022. This session will also address the expanded scope of Annex 1 to include some non-steriles. 824 hours | $32. After this date, reservations can be made on a space-and-rate available basis only. 10:45 | Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution: A Best Practice Holistic Science-Based Approach 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. 13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Taxi fares from DFW are approximately $45-50 one way, not including tip. Guestroom rates are subject to State and Local taxes. Deep understanding of both the abilities and the constraints of each member of the partnership is critical to map a success-oriented development plan. This session will expand on the regulatory challenges we have endured and how we anticipate the future. Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC, SCHOTT AG, 08:30 10:00 | P3 All rights reserved. A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. To make reservations, individuals should click on the reservation link above. Reservations must be secured byFriday, 23 September 2022. 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. 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 Christian Kollecker, Sales Director Aseptic Technology, Harro Hoefliger Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes An Insight from PFS Manufacturing for AI This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. Be inspired, connect with fellow educators, and learn about the latest ideas in teaching and learning and the best educational technology for your classroom! Lets discuss advances in the use of AI in automated visual inspection. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) Moderator: Marc Glogovsky, MS, S.M. Video, photo, and audio recordings are prohibited at all PDA events. A3: Cleanroom Manufacturing: A New Area Across Technology and Processes Paul Gustafson, PIC/S Chairperson, 08:40 | Insights from a Former Regulator PDA Conference 2022 October 18-19, 2022 We are exhibiting at PDA, October 18-19, 2022 taking place in Palm Springs, USA. Peter Gompper, MSc, MBA, Co-founder, Rubitel, An Iterative Process Utilizing Real World Data Collection to Improve Support for Patients with Diabetes Bethesda, MD 20814 USA The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will be live in Palm Springs from the 18th-19th October and we're looking forward to seeing you there. 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. 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 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! PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Kevin J. McMurtrie, Global Business Manager, Documentation/Transfer Systems, Veltek Associates, Inc. Tel: +1 (301) 656-5900 15:30 | Water Systems and Other Critical Utilities Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. B-Lot, 48 hours | $13 Please call 214 849 6831 for bus information. Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? 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. Compared to it, Palm TX looks much better it was . The conference must talk about all the children in your household, even if the people there are only . Technical and Regulatory Considerations for Implementing a PFS and AI Device Platform Dallas, TX Tim McLeroy, Executive Director, Marketing & Patient Services, Noble International, C1: New Technologies and Approaches in Manufacturing 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. 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. Markus Wierzoch, Senior Director Design + Human Factors, Eli Lilly and Company, 09:00 | New Product Introduction and The Patient Experience: Thinking Beyond the BLA Estimated Taxi Fare 7 USD (one way). [emailprotected], Tel: +1 (301) 656-5900 ext. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG, 14:00 | Q&A with Additional Panelist
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