In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros. Continue reading
Tag Archives: Cindy Fazzi
#93 – CAPA SHOULD NOT BE A DREADED FOUR LETTER WORD – CINDY FAZZI
#54 – REPORT HIGHLIGHTS NEED TO ADDRESS ROOT CAUSE OF R&D – CINDY FAZZI
Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on “enhanced clinical trial designs” that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development. Continue reading
#39 – REGULATIONS VARY WORLDWIDE BUT RISK MANAGEMENT IS COMMON DENOMINATOR – CINDY FAZZI
To compete in today’s global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management. Continue reading