Lilly Is 2017 Overall Winner
François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson, speaks with PE about his career, dedication to preventing drug shortages, and thoughts on the ongoing hurricane-recovery efforts in Puerto Rico. Sallans was honored with the Max Seales Yonker Member of the Year Award.
COVER: François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson, was honored with the Max Seales Yonker Member of the Year Award at the 2017 ISPE Annual Meeting & Expo Membership and Awards Breakfast in San Diego, California. We talked with him about his career, dedication to preventing drug shortages, and thoughts on the ongoing hurricane-recovery efforts in Puerto Rico.
FEATURE: Global health care leader Eli Lilly and Company was named the 2017 Overall Winner of ISPE’s Facility of the Year Awards for its Continuous Direct Compression Manufacturing Kits 2 & 3 projects in Indianapolis, Indiana, and Carolina, Puerto Rico. We take another look at these state-of-the-art GMP OSD facilities.
SPECIAL REPORT: The development and adoption of serialization and track-and-trace programs are allowing pharmaceutical companies to identify, capture, and share data to achieve end-to-end product traceability. Our Special Report gets a bird’s-eye view of J&J’s serialization and traceability programs, and explores how Lilly leveraged serialization to secure its supply chain.
Workflow-based technology in the clinical trial continuum encourages process optimization, helps break down silos, enhances performance quality, and has a measurable effect on the electronic trial master file.
They say that ongoing growth is the key to a fulfilling career. If that holds true, young professional Lise Heyninck of Belgium has the mindset and drive to build a long and successful career in the pharmaceutical industry.
Does electron-beam surface decontamination radiation damage COC syringes? Experimental investigations confirm that no measurable dose is delivered if irradiation parameters are selected correctly. Even a dose of a few kGy (equivalent to a few 0.1 Mrad) would not cause significant change.
Every business has legal, economical, and ethical objectives that range from mandatory safety to commercial goals to corporate citizenship. Businesses undertake a certain amount of risk to achieve these objectives. The balance between risk and reward is an ongoing challenge regardless of the activities involved. The bowtie technique can be used to visualize, assess, and manage...
ISPE's Process Capability team has developed an industry-specific maturity model that can help companies design a robust process-capability program and compare it to those of their peers. The model has been substantiated by surveying 15 companies.