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

🚨Last chance to secure your exhibition or sponsorship package for the PDA BioManufacturing Conference 2024! Exhibition registration closes on 09 August! Sign up today! With over 160 industry leaders expected to attend, seize the opportunity to elevate your market presence and connect with a diverse audience. 📈 Choose from tailored sponsorship packages designed to meet your marketing goals and budget. Act now! Secure your spot before registration closes on 09 August. https://bit.ly/3xFksjd

Check out our Design, Operation, and Qualification of Pharmaceutical Water Systems online training 31 July- 02 August! This live online training course provides a summary of compendial water systems from generation through storage and distribution. After completion of this course, you will be able to: - 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 - Understand the numerous potential pitfalls that should be addressed for compendial water systems - Recognize the importance of system monitoring including sample collection, and analysis. For compendial water samples, understand the value of “delivered” water samples - Understand the importance of a comprehensive proactive maintenance program in eliminating costly unplanned shutdowns Register today to be apart of this immersive online training experience! https://bit.ly/3VzZQQr

The national, regional and often site-specific regulations governing sterile manufacturing are challenging for even the most experienced manufacturing professional. Keeping track of so many variations and ensuring compliance with manufacturing activities across regions is an absolute must for international pharmaceutical manufacturing professionals and the companies they represent. We want to hear from you! This topic is the main focus of 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 brings forward the information you need to ensure compliance of your aseptic filling operations with Good Manufacturing Practice (GMP) for all major market countries and regions. Learn more at pda.org/gmp2024 #sterilemanufacturing #GMP #pharma #regulatorycompliance #asepticfilling

The agenda is out now! Join us at the PDA Manufacturing Meets Legislation Workshop from 04-06 September in Berlin, Germany. This interactive workshop is designed to unite experts from the pharmaceutical industry and the legislative sector to address current challenges and share best practices in drug manufacturing in line with the latest legal regulations. This workshop will serve different topics in four modules: - Preparation for EMA Inspectors Working Group Dialogue - Impact of Planned PFAS Ban on the Pharmaceutical Industry in Europe with speakers from Eli Lilly, Merck, and Fraunhofer Institute - Challenges and Opportunities in Pharmaceutical Manufacturing in Europe with experts from the EDQM, Merck, Tigen Pharma, West, and Vils - Overview of the Current Changes in the EU Regulatory Framework with representatives from Amgen, Airfield, and the Green Innovation Group Be sure to register today! https://bit.ly/3wB3yC5

Check out Janeen Skutnik-Wilkinson discuss the value of the PDA/FDA Joint Regulatory Conference 2024!

Enhance your skills in aseptic filling! Join our comprehensive training course on aseptic filling, starting with EU GMP Annex 1 and regulatory requirements. Dive into barrier types, material transfer, and the importance of first air. Learn about primary packaging containers, filling technologies, and environmental risk analysis. Get hands-on experience with filling path installation, indirect product contact parts, and sterile filtration. - Understand Annex 1 requirements and barrier technologies. - Master the setup of filling paths and indirect contact parts. - Explore first-air considerations and filling line design. - Conduct environmental monitoring risk analysis. Limited space is available, so secure your spot today! 📅 04-05 September 📍 Training course venue: groninger Group facility in Crailsheim, Germany Supported by: Trainers from groninger Group, SKAN, Merck Life Science, PSM - Your Pharma CDMO, and STERIS Learn more and register: https://bit.ly/3RR2Wj6

Learn more about our Fundamentals of an Environmental Monitoring Program training! Get hands-on experience with environmental monitoring equipment and media, empowering you to develop a robust program tailored to your facility’s needs! During this course you will: - Learn about standards, surveillance support systems, and validation systems - Practice developing a surface and air environmental program for PDA’s cleanroom - Explore rapid micro method implementation - Dive into risk assessments and EMPQ creation - Receive a complimentary copy of the PDA Technical Report on this topic as an additional tool to take back to your organization Be proactive! Register now to ensure pharmaceutical product quality and safety: https://bit.ly/3VdwAQq #environmentalmonitoring #sterilityassurance #qualitycontrol

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