Course offering number:0711-721
Course ID:
2184
Computerized Systems Used in Clinical Investigations: the New FDA Guidance
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is important for those in the Pharmaceutical, Biotechnology and Medical Device Industries including:-
Study sponsors
- Clinical Investigators
- IT Professionals
- Data Management Centers
- Contract Research Organizations (CROs)
- Institutional Review Boards (IRBs)
- Clinical Software Vendors
- Computer System Validators
- Project Managers
- Management
- Other Professionals Who Use or Design Computer Systems for Clinical Studies
Description
This program will provide key insights and features of the new FDA Guidance. Attendees will learn what the FDA expects when you use computer systems for clinical studies.how 21CFR Part 11, (ERES) applies and how this can help to support the EudraVigilance requirements for the European Medicines Agency.
This is an important and very timely program that can help to better plan the more efficient and compliant use of computer systems to support clinical studies.
Module 1:
Study Protocols
SOPs
Security
Module 2:
Audit Trails
Data Management
Change Control
Module 3:
Personnel
EMEA Standards
EudraVigilance Reporting