PDA - Parenteral Drug Association

Dear PDA - Parenteral Drug Association Members! Register for our next Virtual Meeting IG Pre-Filled Syringes Wednesday, November 27, 4:00-5:00pm CET Our Topic: How can you develop a combination product while meeting regulatory requirements and your company's timeline and cost expectations? Panelists: Frank Bamberg, Benedikt Balzer, Edwin Lyons, This session will show what ideas and ways have been found to successfully develop and test different primary packaging and devices. It will also look at the interaction of internal functions such as RA, secondary packaging, etc., as well as pharma's expectations in terms of support from suppliers and CMO. What each design control document should look like is not the focus here, but the different development phases and their challenges in terms of communication with internal and external partners will be presented. Together with Frank Bamberg, Philippe Lauwers. Alessandro Morandotti I welcome you to this virtual meeting. Log-in information for the meeting will be EMAILED to all our current IG members, so make sure you have joined the Interest Group Pre-filled Syringes. Connect with the https://lnkd.in/ei4R93cN and be part of the discussion!

Mark your calendars and make your vote count! Join us at the PDA ICH Q5A R2 Essentials: Training and Practical Applications Workshop 2025 on 23 June 2025 in Gothenburg, Sweden, right before the PDA Virus Conference 2025. Learn more: https://lnkd.in/e4-tPBQE #pda #pdavirus

Don’t miss out on the Design, Operation, and Qualification of Pharmaceutical Water Systems Training Course. This online training course provides an overview of compendial water systems from generation through storage and distribution. It’s ideal for professionals involved with bulk compendial water systems from design, engineering, operation, manufacturing, Quality Assurance, compliance, maintenance, monitoring, and excursion evaluation. 📅04-06 December 📍Online During this course, you will: • Evaluate the design of a compendial water system, considering feed water characteristics, from generation through storage and distribution • Understand the importance of initiating system qualification throughout the design, engineering, risk assessment, installation, commissioning, protocol generation/execution, procedure preparation, monitoring program preparation, and proactive maintenance program • Recognize the importance of system monitoring including sample collection, and analysis Learn More: https://hubs.ly/Q02W_Cjd0

Shape the PDA Good Digital Manufacturing Conference 2025! We're constantly looking to improve, and your feedback is essential to shaping future events. 💬 Could you take a few minutes to complete our survey? Your responses will help us make each experience even better. Plus, it’s a chance for you to share what you love and what we can improve! It will only take 2 minutes! 👉 Take me to the survey: https://lnkd.in/eVnuWS4P Thank you for helping us grow, and we look forward to reading your feedback! #pda #pdadigital

Join Us at the PDA Visual Inspection Workshop 2024! Be invited to our one-day Visual Inspection (VI) Workshop supported by the PDA Visual Inspection Interest Group on 03 December 2024 in Berlin, Germany. This event brings together industry experts and practitioners for a focused, interactive experience on practical VI topics and challenges. Key Topics: - Difficult-to-inspect products (DIP), including ATMP/CGT therapies - Acceptance Sampling/AQL Inspection tailored for small batches - Updates from A3P Particle Interest Group on Visual Inspection Expert Speakers: - John Shabushnig, Insight Pharma Consulting, LLC - Romain Veillon, GSK - Massimo Frasson, Brevetti-CEA - Valerie Rautureau, Eli Lilly and Company - Elise Tourlet, UCB You may also want to take advantage of the training course offered immediately following the Workshop in the same venue. Both PDA An Introduction to Visual Inspection: A Hands-On Course (🔗 https://bit.ly/4egFPIp) and PDA Mastering Automated Visual Inspection (🔗 https://bit.ly/4evLXNg) will be taught on the days following the workshop in the same venue. Don’t miss this opportunity to enhance your VI knowledge and connect with fellow professionals! View the workshop program and get registered today: 🔗 https://bit.ly/45on0yT

Submit your podium or poster abstract for the PDA Good Digital Manufacturing Conference 2025, taking place on 20-21 May 2025 in Basel, Switzerland. Showcase your work alongside industry leaders and contribute to the future of digital manufacturing! Key topics include: - Digital Transformation - AI in Pharma - Data Life Cycle Management - Manufacturing & Quality Control - Sustainable Digitalization 👉 Submit your non-commercial abstract by 29 November 2024 and maximize your visibility at this prestigious event: https://bit.ly/3A8c39I Learn more: https://bit.ly/4fhE7pN #pdadigital

Co-Chairs Arielle Anahory and David Short offer valuable insights into their Drug Compounding Interest Group.

🚨 Attention Injectable Drug Product Professionals! 🚨 Don't miss this valuable training opportunity! PDA An Introduction to Visual Inspection: A hands-on course, that covers the fundamentals of visual inspection methods for injectable products, focusing on detecting visible particles and container defects. With a perfect blend of classroom learning and hands-on lab exercises, you'll develop essential skills for manual, semi-automated, and automated inspections. Who should attend? - Manufacturing & Quality Professionals - Validation & Manufacturing Engineers - Technical Support Staff - Product Development Scientists Learning Objectives: - Master global regulatory requirements - Understand patient risk from visible particles - Implement compliant inspection processes Register now to advance your expertise: https://bit.ly/4egFPIp

Call for Abstracts: PDA Good Aseptic Manufacturing Conference 2025 is still open until 24 November 2024! 📅 This year's theme is "Excellence in Aseptic Manufacturing: Bridging Compliance, Innovation, and Sustainability," we are particularly looking for groundbreaking developments that push the boundaries of scientific excellence and practical applications in this vital field. If you are working on innovative solutions or have new insights into any of the relevant topics, this is your opportunity to showcase your work to leading experts and peers. Submit your abstract and contribute to the advancement of aseptic manufacturing! 💡 Relevant Topics Include: - Aseptic Processing Innovation - Regulatory Developments - Sustainable Manufacturing Practices - Sterility Assurance Challenges 🔗 Submit your abstract here: https://bit.ly/3BjlVO3 Let’s shape the future of aseptic manufacturing together! Learn more about the conference: https://bit.ly/3YD6SIo #pdagoodaseptic

Explore the images and highlights from PDA's recent hands-on training course on single-use systems at the Sartorius Stedim Biotech facility with Sartorius trainers and Dominic Parry from Inspired Pharma Training! The event was an incredible experience, offering practical learning and valuable knowledge exchange. 📅 Mark your calendars for the next edition: 03-05 June 2025! Don't miss the opportunity to participate in next year’s course and gain in-depth expertise in this rapidly evolving field. Registration for the 2025 session is now open! 👉 Check out the agenda now: https://bit.ly/4htQ8L5