Quality Issues in GxP Functions: Some Inconvenient Truths
Friday, October 6, 2017 12:30 PM - 1:30 PM EDT
The journey from translating a discovery into a new therapy, or finalizing a new manufacturing production process, or ensuring quality in any technical function, is usually long and arduous. These functions require multifold types of expertise, including the major components of development, clinical trials, regulatory issues, cost-benefit studies, manufacturing certification, system testing and process excellence.
In addition to running the scientific and/or technical gauntlet, any potential new drug or process must clear the many regulatory and compliance hurdles. Despite the high volume and oftentimes compulsory nature of training in these areas, the error rates in all of these areas are consistently high.
Join us for this LTEN webinar, as John Constantine, SVP of Orchestrall and former LTEN Board president, discusses how risk and uncertainty continue to rule the business processes in life sciences. John will outline how the lack of consistent quality is the primary driver for continued unacceptable error rates and discuss how quality issues in the conduct of technical processes continue to be prevalent.
At this webinar, John will:
• Review and discuss current and past trends in “483” findings in the conduct of clinical trials and manufacturing processes.
• Discuss the lack of root cause analysis in these processes, which leads to training being applied where it cannot be effective.
• Challenge opinions on the technical and, more controversially, non-technical root causes of quality issues.
• Discuss thoughts and ideas on how learning professionals can help our business partners improve these processes.
| John Constantine, SVP of Orchestrall and former LTEN Board president
Register today for this free, LTEN webinar. Not an LTEN member? Join today and realize the value.