Regis Technologies invites you to a seminar on data integrity from guest speaker Michael Anisfeld of Globepharm Consulting. Read his abstract below for more details. A light breakfast will be served.
Join us for coffee and chemistry on Friday, October 20th, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
While medicines may save lives, they also have the potential to do great harm. The difference may depend on the integrity of the data generated during drug development, clinical trials, manufacture, and testing. Managing complex pharmaceutical data systems in a global marketplace is challenging and regulatory enforcement agencies around the world have responded by bringing focus to concerns over data integrity.
The presentation covers the following issues:
- What is data integrity and why is it important
- Deep dive into FDA warning letters
- ALCOA principles
- Relationship between good documentation practices and data integrity
- Data integrity in laboratories
- Security including user access, privileges, audit trails, archiving and retrieval
- Embedding data integrity into your quality systems