Understanding Data Integrity Seminar
Regis Technologies invites you for 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.
Understanding Data Integrity
Michael Anisfeld
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
- Imbedding data integrity into your quality systems
Michael Anisfeld
With over 35 years expertise in the healthcare industry, Mr. Anisfeld has held senior management positions in International Technology Transfer, Quality Assurance, and Production. In the course of his career, he has designed pharmaceutical, medical device, and bulk pharmaceutial chemical facilities in four countries. A member of the faculty of University of Illinois, where he lectures in Pharmaceutical Technology, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Business Administration (MBA), and Management (MSM).