PDA - Parenteral Drug Association

Keeping pace with the global regulatory requirements can be overwhelming for anyone! Our workshop, based on PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book (newly revised for release in fall 2024) and its updated comparison toolset, brings forward the regulations and information you need to ensure the compliance of your aseptic filling operations with Good Manufacturing Practice (GMP) for all major market countries and regions. Attend the workshop to become informed and empowered about sterile manufacturing regulations and compliance from U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan. ➡ Why attend? You receive not only immersion in the updated book content but will immediately learn how to use the comparison tool set (used by pharma manufacturing professionals around the world) to help identify gaps that may exist in your current operations and hear directly from the industry experts who literally wrote the book. Plus, receive an early release copy of the book and toolset at no additional cost! View the agenda and register: https://lnkd.in/erGKam2J #sterilemanufacturing #GMP #pharma #regulatorycompliance #asepticfilling

Join us for an exciting new training experience on PDA EU00193 Electron Beam Sterilization for Inline Transfer Systems at the SKAN Academy. This event will take place at the SKAN Headquarters in Allschwil and the ebeam Competence Centre in Stein. This interactive course will cover: • Basics of Electron Beam Systems • Material Effects & Validation • Regulatory Compliance • Hands-on Demonstrations The training is scheduled for 18-19 September 2024, in Allschwil, Switzerland, with a transfer to the ebeam Competence Centre in Stein on the second day. Spaces are limited, so reserve your spot now: https://bit.ly/3K7UJ64

As we anticipate the upcoming annual PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024 in Phoenix this October 22-23, Shirish Ingawale, a member of the planning committee, gave a sneak preview.

Keeping pace with the global regulatory requirements can be overwhelming for anyone, especially when expectations around the world continue to change. We want to hear from you! This topic focuses on our Global Sterile Manufacturing Regulatory Guidance Comparison Workshop, based on PDA’s newly revised Global Sterile Manufacturing Regulatory Guidance Comparison Book and its updated comparison toolset. This workshop presents similarities and differences in guidelines for aseptic processing from seven GMP guidances: U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan. Learn more at pda.org/gmp2024 #sterilemanufacturing #GMP #pharma #regulatorycompliance #asepticfilling

Take our Survey! After almost one year of the enforcement of the EU GMP Annex 1: Manufacture of Sterile Medicinal Products, it is time to evaluate some of the most relevant challenges and benefits faced by the manufacturers related to the implementation of the new requirements. The PDA Annex 1 Implementation Interest Group is conducting a survey to better understand the impact of the revised Annex 1 and to provide the industry with valuable information and insights on current challenges and learnings in the spirit of continuous improvement. Results will be announced at the Pharmaceutical Microbiology Conference (07-09 October in Washington, DC) and Annex 1 Workshop (05-06 November in Dublin, Ireland). Your input is essential to support the understanding of current challenges. Be sure to participate in the survey by 18 August! COMPLETE THE SURVEY https://bit.ly/3SeW7bC

Join us in Gothenburg, Sweden for the PDA Biomanufacturing Conference! As global health challenges like infectious diseases and cancer evolve, our two-track event is a must-attend. Explore new technologies, including AI, digital twins, CMC strategies, and regulatory frameworks, supporting rapid access to vaccines and biotherapeutics. Highlights include: - Keynote presentation from a patient perspective - Case studies and expert views on biopharmaceutical innovations - Sessions on advanced modeling, manufacturing capacity, and sustainability - Networking with industry professionals, academics, and regulatory representatives from organizations like the U.S. FDA, MHRA, and CEPI Check out the agenda and join us for cutting-edge insights, an exhibition, a guided poster session, and unparalleled networking opportunities. It's also your last chance to book your booth! Space will be up by 09 August. Save your booth now: https://bit.ly/4d537zD 👉 Make sure to register: https://bit.ly/3xFksjd This conference has been kindly supported by our media partner Samedan Ltd. #biomanufacturing

Exciting training opportunities in Gothenburg, Sweden! We're thrilled to announce three cutting-edge training courses designed to elevate your expertise in the pharma industry. Whether you're focusing on regulatory compliance, managing technology transfer projects, or advancing your knowledge of recombinant proteins and biosimilars, we've got you covered! CMC Regulatory Compliance Strategy for ATMPs & CGTPs 📅 23-24 September 🔍 Dive into the latest regulatory strategies and compliance requirements for Advanced Therapy Medicinal Products (ATMPs) and Cell and Gene Therapy Products (CGTPs). Stay ahead in this rapidly evolving field! Sign up today: https://bit.ly/3yTnuRu Are you planning to join the PDA BioManufacturing Conference 2024 from 24-25 September? Make sure to extend your stay by registering for one of the following training courses: Managing Technology Transfer Projects in Pharma 📅 Date: 26-27 September 2024 💡 Gain insights into the best practices and methodologies for successful technology transfer projects within the pharmaceutical industry. Enhance your project management skills and ensure smooth transitions from development to production. Register: https://bit.ly/3z7h7dr CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, and Biosimilars 📅 Date: 26-27 September 🧬 Learn about the critical regulatory frameworks for recombinant proteins, monoclonal antibodies, and biosimilars. Equip yourself with the knowledge to navigate complex compliance landscapes and drive your biopharmaceutical products to market success. Learn more: https://bit.ly/3RAxGVt Don't miss these opportunities to enhance your professional development and stay at the forefront of the pharma industry. Register now to secure your spot!

Check out this PDA Expert Interview with Dr. Joseph Frantz, MS, PhD, as he discusses the importance of the PDA Global Sterile Manufacturing Regulatory Guidance Comparison Workshop 2024!

Calling on all professionals and teams who are involved with the manufacture of aseptically filled sterile drug products for markets around the world. Join us at the PDA Global Sterile Manufacturing Regulatory Guidance Comparison Workshop 2024. The workshop, based on PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book (newly revised for release in fall 2024) and its updated comparison toolset, brings forward the regulations and information you need to ensure the compliance of your aseptic filling operations with Good Manufacturing Practice (GMP) for all major market countries and regions. 📅11-12 September 📍 Washington, DC What you will gain: • You receive an early release copy of the book and all its tools and supporting documents • A two-day engaging, educational and practical workshop with hands-on experiences filled with practical real-world advice to ensure understanding and appropriate manufacturing compliance. • Immediate application of new knowledge and understanding via facilitated and group-led discussions, case studies, and role-playing exercises. • Industry expert presentations on Good Manufacturing Practice (GMP) specific to aseptic processing To register and view more info about the workshop, visit: https://bit.ly/4d77cDk

Call for Abstracts! Abstracts are now being accepted for podium or poster presentations at the 15th edition of the PDA Parenteral Packaging Conference on 25-26 March 2025. The location will be announced soon. Do you have different test methods, innovative packaging development, or strategies that would be helpful to everyone in the industry, from early career professionals to manufacturing leaders, in facing today’s challenges? If so, we want to hear from you! Abstracts on a wide range of topics will be considered, including, but not limited to: • Applications, Benefits, and Limitations of Glass and Polymer Containers • Validation of Packaging Solutions and Packaging Performance • Fill-Finish Operations and Filling/Sealing Technologies and Controls • Impact of Planned Ban of Per- and Polyfluoroalkyl Substances (PFAS) Learn more about the suggested topics: https://bit.ly/4cV3BZ8 Help influence the agenda while showcasing your latest work to a broad audience of industry professionals. Submit your abstract by 06 September for consideration: https://bit.ly/3zRusqy All conference updates will be shared on the event webpage: https://bit.ly/465cDjY