PDA - Parenteral Drug Association

Introducing the GMP Comparison Workshop in Washington, DC! This hands-on workshop provides the essential regulations and information that will help in ensuring compliance with Current Good Manufacturing Practices(cGMP) in any country or region where sterile drug products are marketed. This workshop is based on the forthcoming revision of the PDA Global Sterile Manufacturing Guidance Comparison book. This document compares seven regulatory documents, including guidelines from U.S. FDA, the European Commission, WHO, PIC/S, Canada, Japan, and China. Workshop Highlights • Access invaluable information shared in the book and receive a free copy of the comparison tool to take back to your organization. • Dive into two action packed days filled with practical advice, real-world scenarios, and expert presentations. Participate in lively discussions, immersive case studies, and interactive role-playing exercises. • Learn how to build a robust training program and conduct an effective gap assessment, hear about significant misalignments across manufacturing guidances, and understand the impact of quality management systems on operations Don’t miss out on this highly educational and engaging workshop. Stay tuned for a sneak peek into the workshop and exclusive insights from the experts themselves! #PDAgmp #CGMP #asepticprocessing #pharma Check out the agenda: https://bit.ly/4eKBb5P

Dive into freeze drying at this five-day hands-on training course taking place at Martin Christ Gefriertrocknungsanlagen GmbH in Osterode am Harz, Germany! 📍 09-13 September Learn the ins and outs of freeze drying, also known as lyophilization, a crucial process for enhancing the stability of biopharmaceuticals. This comprehensive training will take you through the entire freeze-drying process, from freezing to primary and secondary drying. Reasons to attend: - Deep Dive into Freeze-Drying: Understand the structure, operating principles, key components of freeze-dryers, and remedies to system malfunctions. - Hands-On Learning: Engage in interactive training, exercises, and experiments in both lab and production settings. - Expert Guidance: Develop a freeze-drying recipe and troubleshoot system malfunctions with the help of experienced experts. - Technical Mastery: Learn about technical support, sensor calibration, system qualification, preventative maintenance, and automated loading/unloading systems. Limited space is available! Make sure to sign up today: https://bit.ly/3VMuSap #freezedrying #lyophilization #biopharmaceuticals

PDA Fundamentals of Aseptic Processing Training Course On 30-31 July 2024 in Berlin, Germany, you will be able to master the essentials of aseptic processing with our comprehensive training course. Gain hands-on experience and deep insights into environmental monitoring, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, and regulatory requirements. Course Objectives: • Learn how to evaluate and improve current aseptic processing procedures. • Assess contamination risks with airflow visualization. • Develop effective environmental monitoring programs. • Understand the importance of filter integrity testing. • Ensure proper interventions in cleanroom fill operations. • Apply basic microbiology concepts to aseptic processing. • Master sanitization techniques and disinfectant evaluations. • Interpret regulatory requirements for sterile product manufacturing. Don’t miss this chance to elevate your aseptic processing skills and ensure product safety and compliance! Register Now: https://bit.ly/3KivLRs

Don't forger to sign up for the FREE Validating Virtual Reality Training for Compliance in Pharma Webinar in collaboration with Innerspace - The Simulator Company! 📅 09 July 🕐 14:00-15:30 CEST As the pharma world embraces digital technologies, compliance with regulatory frameworks and validation of these solutions are crucial. Validating VR training approaches is a significant challenge, but once solved, it offers substantial benefits to people, the planet, and business profitability. Join us to learn from Linda Wildling (Takeda) and Markus Windisch (Innerspace) what a validated VR training approach under regulations like the CFR21 framework could look like and how VR can harmonize global training methods. Secure your spot: https://bit.ly/3VydiFS #pharma #VR

Taking place from 9 to 11 September in Washington, D.C., this FDA co-sponsored event is the premier pharmaceutical Current Good Manufacturing Practice (CGMP) conference in our industry. Attend to hear directly from Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), U.S. FDA, and Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER), U.S. FDA. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive sessions and practical case studies that will provide insight into the everyday application of CGMP and methodologies. Save up to 20% during our early registration period ending 17 July. Get more information and take an in depth look at the agenda: https://bit.ly/4eOt1cA #PDAFDA #FDA #CGMP

The PDA Letter completed its month-long examination of #AI with an analysis of public comments on FDA/CDER's AI/MS discussion paper. #pharmaceuticalindustry #biotech https://lnkd.in/eT3NTszk

We are thrilled to have Christian Helbig as a member of the Program Planning Committee for the PDA Universe of Pre-filled Syringes and Injection Devices Conference this October in Phoenix, Arizona! The conference will feature over 140 exhibitors, networking opportunities, and numerous discussions. Stay tuned for more updates on our exciting lineup and be sure to check out https://bit.ly/3XizuGq for the full event agenda! #pharma #PDAups #drugdelivery #prefilledsyringes #injectiondevices

Gain insights into developing an effective Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy tailored for biopharmaceuticals at our 26-27 September training in Gothenburg, Sweden! This comprehensive two-day training will equip you with the knowledge and tools needed to navigate the complex regulatory landscape, ensuring your products move seamlessly from first-in-human (FIH) clinical studies to market approval. Why Attend? - Expert Guidance: Learn from real-world examples and expert insights on CMC strategies that worked and those that didn’t. - Regulatory Focus: Understand CMC regulatory guidance from FDA, EMA, and ICH. - Hands-On Learning: Gain practical guidance on creating a cost-effective, risk-based CMC regulatory-compliant strategy for protein-based biopharmaceuticals, including recombinant proteins, monoclonal antibodies, and biosimilars. Grasp the principles of an effective CMC regulatory strategy for biopharmaceuticals and learn to avoid major CMC delays in clinical development or market approval due to ineffective compliance strategies. Learn more and register: https://bit.ly/3RAxGVt

Breaking News: U.S. Supreme Court Ends Chevron Deference Decision Learn more: https://lnkd.in/exk565Gh #SCOTUS #pharmaceuticalindustry

The public review period is open until 12 August! This standard is intended to guide organizations to help them determine which tools or techniques are most appropriate for assessment of quality culture maturity based on their specific circumstances. Learn more and submit your comments: https://bit.ly/3L3F0p3