Understanding Data Integrity Part IV: FDA Warning Letter Examples and Q&A

Описание: On October 20, 2017, Regis Technologies hosted a seminar on "Understanding Data Integrity" at its facility. Guest speaker Michael Anisfeld, President of Globepharm Consulting, delivered a technical talk on the basics of data integrity and its importance in drug development as the data from clinical trials, manufacturing, and testing can alter whether a medicine has the potential to save lives or cause harm. This final chapter showcases multiple different warning letters from the FDA. At the conclusion, Anisfeld answers the audience's questions.