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

Get your FREE copy of our Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages! This report is a great opportunity to view the content we release exclusively to our members. Get informed, get the data and get the plans you and your company need. Download your free copy: https://bit.ly/4bKiDQR

Fallout from the Supreme Court Decision to Reverse Chevron Deference #regulation #supremecourt #legalactions #pharmaceutical #manufacturing #production #engineering #legislation #deference

Join us for an in-depth training course on freeze drying (lyophilization), a critical technique in the pharmaceutical industry for stabilizing both drug substances and products, especially biopharmaceuticals. With roughly 50% of these products currently freeze-dried and numbers expected to rise, mastering this process is essential. The training course covers: - The freeze-drying process: freezing, primary drying, and secondary drying - Operating and maintaining complex, computer-controlled freeze-dryers - Developing freeze-drying recipes - Technical support, sensor calibration, system qualification, and preventative maintenance - Cleaning and sterilization requirements Interactive training, hands-on exercises, and real-world problem-solving sessions are integral to this course. Network with experts and peers while gaining practical insights. Register now to enhance your skills and expertise in pharmaceutical freeze-drying: https://bit.ly/3VMuSap

If the equation SUS plus GMP results in SOS to you, then you should sign up to this two-day course taking place from 30 September-02 October 2024 at the Sartorius Stedim Biotech facilities in Göttingen, Germany. Here you will learn from and discuss with technical trainers and specialists, such as Dominic Parry from Inspired Pharma Training, and experienced Sartorius Stedim Biotech trainer for data handling and GMP regulations, about how to implement and operate single-use technologies in a GMP-controlled environment. During the optional third day, you will have a look at the manufacturing of single-use bioreactor bags and filters, which will be followed by a visit to the Sartorius Application Center. During the visit, you will be able to see and test complete process solutions, from molecule discovery to large scale biomanufacturing. Don't miss out! https://bit.ly/3Qs4rD0

Don't forget to send your submissions for the PDA Visual Inspection Forum 2025! 📍 10-11 March 2025 📅 Raleigh, NC Create a positive impact by sharing your expertise and insights! We are seeking abstracts on a wide variety of topics focusing on challenges and innovations in the field of visual inspection, including but not limited to: • Application of deep learning and artificial intelligence • Component quality and supplier qualification • Risk-based validation case studies • Development and management of test kits • Regulatory and compendial requirements Learn more: https://bit.ly/4dzNXTt Submit: https://bit.ly/4eoyS8h #PDA #PDAvisual #visualinspection

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