The 2016 Pharma EXPO, a joint venture of ISPE and PMMI, will take place 6 – 9 November at the McCormick Place Center, in Chicago, Illinois. Held in conjunction with the Pharma EXPO is the Pharma EXPO Conference. This conference is a three-day, commercial-free event organized by ISPE held on 7 – 9 November. The conference features five sessions per day, covering three tracks: Manufacturing Operations, Compliance Trends, and Pharmaceutical Packaging. One of the interesting aspects of the conference is that it brings together professionals not only from pharmaceutical engineering, but also from other fields who are in attendance, such as food and beverage, electronics, chemical, and petroleum industries, making for a rich discussion on quality manufacturing, as each industry has a unique history and experience with current and emerging practices such as continuous manufacturing. Mathew Gorton, Regional Sales Manager, Bosch Packaging Technology and one of the co-chairs of the Manufacturing Operations Track, says that an overarching key question he and his colleagues are thinking about is “How can we accelerate manufacturing production in the pharma industry to meet growing and fast-changing demand — be more efficient and agile?” A variety of major trends in the industry are reflected in the session topics across the conference program, from modular construction and the role of data integrity to the fast-growing demand for biologics and impact of robotics and the “Internet of Things”. To give one example of the interdisciplinary perspectives and experiences brought together at the Pharma EXPO Conference, one of the speakers in the Pharmaceutical Packaging Track, Patrick Boyle, President, Skillpad Canada Inc., will address “Operator Readiness for Serialization.” Boyle’s experience includes working in the aerospace industry, which has been dealing with complex serialization issues across a global supply chain for years. Boyle’s presentation will include an overview of serialization, track and trace, and authentication compliance issues and a focus on practical “inside the plant” issues impacting operator readiness, from digital concerns when packaging lines are configured and situational awareness of operators to useful tools for event mapping and the handling of normal and non-normal exception events. Learn more about the Pharma EXPO Conference education program.
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...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
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...