Alastair Willoughby, MEng, Head of Mechanical Engineering, Team Consulting, 16:25 | The Route to Further Sustainability Improvements for Autoinjectors Moderator: Deborah DuFresne, Head of Pipeline and Due Diligence, Pfizer. decide how to keep your child safe. IG2: Process Validation and Lyophilization. 07:15 | Flexible Manufacturing Platforms with Integrated Automation Solutions Join us in Palm Springs for the ultimate educator experience! This flagship conference offers attendees the opportunity to learn about current issues related to manufacturing and quality assurance. Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH. Katherine Huffer, Manager, R&D, Verification, West Pharmaceutical Services, Inc. Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG. Ontario International airport (ONT) is 70 miles from Hotel. Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. Tracy Moore, Director, TM Pharma Group Ltd, 09:00 | Q&A with Additional Panelist Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. Please call 214 653 1101 for train information. Herve Soukiassian, Assoc. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Tel: +65 64965504 Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company 10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 15:45 | Integrating Sustainability in Device and Packaging Products: Strategies and Opportunities PDA Conference October 18th-19th 2022. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. 08:00 | Welcome Remarks from Workshop Co-Chair After two years, the return to normal is still uncertain. PDA 2022 | Cambridge Pharma HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium 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. 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. 08:00 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment Bethesda, MD 20814 USA 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. Marc Glogovsky, MS, S.M. Arne Rehm, Senior Product Manager RFID/NFC Solutions, Schreiner MediPharm Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Please contact us if you are entiteld to receive a discount. Rob Hall, Design Team Manager - Product Design, Owen Mumford. Swagat Sangamnerkar, Director, MS&T, Renaissance Lakewood LLC, Key Design Considerations for an Emergency-use Injection System The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. You can't miss the closing session "Investing in the Future," featuring Donald Jones, JD, MBA, Chair, Cardiff Ocean Group, and James J. Collins, Jr., MBA, President, Pharmaceutical Delivery Systems LLC. 13:00 13:50 | P7: Production Technologies, Part 2 Connecting People, Science and Regulation. Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. The New Normal in Injectable Drug Delivery. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA. Moderators: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc. and Mathias Romacker, Executive Advisor, Kymanox. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). 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. These emails are sent by scammers. Radish Lot, 48 hours | $13 A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. Max Fill Volume Evaluation for Pre-filled Syringes The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The group rate is $199 for single or double occupancy. 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. 10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies An Insight from PFS Manufacturing for AI We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. (This applies in particular to costs for submitting documents by courier.). Bethesda, MD 20814 USA 3 people interested. Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. 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. Thomas James, Mechanical Engineer, Key Tech Tibor Hlobik, Sr. Director Product Technology Services, West Pharmaceutical Services, Inc. Jake Keeler, Sr. Duncan Paterson, MSc, MBA, Senior Director, Device Development, AstraZeneca 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! The 2022 PDA Annual Meeting promises to have something for everyone! Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. Learn about opportunities and benefits. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field. 2022 PDA Annual Meeting 2022 PDA Annex 1 Workshop Palm Springs | Speakers The Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel are sold out. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. This session opens our in-depth look at the content of the draft Annex 1. Palm Desert, CA. James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? 13:00 | Cleanroom Design: Classification, Qualification, Air Visualization 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 Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Website| Reservations Link. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot). Iain Simpson,Commercial Director, Phillips-Medisize. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Chelsea Williams, MPH, Manager of Digital Health, SHL Medical. 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! For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Finally, we will learn about regulatory considerations. Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. These emails are sent by scammers. Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. Moderator: Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG, 08:30 | Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. Interested in becoming an exhibitor? Virtual February 28, 2022-March 03, 2022 17th Annual HD Therapeutics Conference. Chuck W. Seipel, Product Specialist, W.L. Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. Sbastien Cordier, Technical Product Manager, Aptar Pharma, From the Users Perspective: The Use of Eye Tracking Technology in Human Factors Studies to Assess and Improve Injection Device Usability B-Lot, 8-24 hours | $19 Lets discuss advances in the use of AI in automated visual inspection. Cancellation requests must be emailed to [emailprotected]. 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device Oct 12, 2022. 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand Young Harris, GA. March 2-3, 2023. Bruce Loxley, Senior GMP Compliance Advisor, GSK Vaccines, 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic 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 Parking at the Convention Center costs $10 daily. Tel: +49 30 436 55 08-0 or -10 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 The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success. Other discounts cannot be applied. Xi Zhao, Senior Scientist, Merck & Co., Inc. Stefan Mangold, PhD, Manager Concept Development, Ypsomed AG, B1: Challenges and Opportunities for Moving Treatments to the Home Setting The ability to rapidly develop and manufacture mRNA vaccines with high efficacy against the SARS-CoV-2 virus is a tremendous public health accomplishment and has spurred widespread interest in mRNA vaccines for multiple infectious diseases and other indications. Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter. Doug Paradis, MS, Chief Technology Officer, Veltek Associates, Inc. 11:25 | Unit Level Syringe Identification and Traceability Cutting Edge of Aseptic Transfer Technology in Regards of ATMPs and ADCs (mAbs) 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. 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. Herve Soukiassian, Ass. Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc. Moderator: Mathias Romacker, Executive Advisor,Kymanox. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs. 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. [emailprotected], 4350 East West Highway, Suite 600 10:45 12:15 | P2: Lessons in Effective Drug-Device Development Partnering The new Annex 1 revision was recently released! 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 D1: Building Back Better: Innovative Options for Audits and Inspections Open letter to the Secretaries of State for Housing and Justice - 10/10/2022. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field.This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . 10:45 | Strategies for Total Contamination Control in an Aseptic Environment Atlanta, Georgia March 05, 2022-March 06, 2022 HDYO's International Young Adults Virtual Congress. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) PDA 2022 - Nemera Interested in becoming a sponsor? Top PFAS Conferences in 2022 | News Direct Page McAndrew, PhD, Director, Scientific Communications, West Pharmaceutical Services, Inc. Electronically-Controlled Needle Free Injections: Understanding Variables Influencing Injection Performance Please contact us if you are entiteld to receive a discount. Statements claiming to offer our attendee lists are fraudulent. Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Effects of Manufacturing Date on Silicon Oil Particles in Prefilled Syringes Benben Song, PhD, Global Product Manager, Pall Corporation, 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness Guangli Hu, Principal Scientist, Merck & Co., Inc. Elastomer Plungers with Fluoropolymer Barrier Films Utility for Emerging Drug Products If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Michelle Hatch, MEng,Senior Human Factors Engineer,Genentech, Inc. C3: From IV to SC: Innovative Approaches to On-Body Delivery Systems Alaska Airlines, Delta and Southwest service this airport. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Radish Lot, 04 hours | $9 15:30 | Water Systems and Other Critical Utilities 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 Brad Womble, Managing Director, Healthcare Strategy, Jabil, Inc. Maggie Reiff, Vice President, Development, ApiJect Corp. At the completion of this conference, attendees will be able to: PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company.