I would like to personally invite you to attend the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, jointly sponsored by and organized with the FDA. If you have been to one of the previous Quality Manufacturing Conferences, you have an idea of the value of this opportunity. If you have never been to this conference before you will immediately see how important and relevant this is to your area of expertise in the manufacturing life cycle. This year promises to meet and exceed your expectations by emphasizing the top priorities from CDERs Office of Pharmaceutical Quality (OPQ) and Office of Compliance and the Office of Global Regulatory Policy and Operations. Highlights of the conference include:
And that is just the tip of the iceberg! Additional highlights include:
Calling all Young Professionals, Senior Leaders, Development, Quality, Engineering, Facility, and Manufacturing Professionals, and everyone involved in the life cycle of manufacturing medicines for patient needs today and in the future, you need to attend! I hope to see you there!
P.S. Don’t miss the Data Integrity Workshop on June 4th, immediately before the 2017 ISPE/FDA/PQLI Quality Manufacturing Conference, with FDA Compliance, Pharmaceutical Industry Compliance and ISPE GAMP® experts, facilitating an interactive workshop on successfully implementing a robust data integrity program avoiding compliance issues. Sign up now: www.ISPE.org/2017-Data-Integrity-Workshop/Register
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
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Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...