FDA`s enforcement of 21 CFR part 11 compliance 2015 is a webinar that covers topics such as:
- What are the inspection trends?
- What is FDA`s most current thinking related to computers and electronic records?
- What are the most frequent deviations for computer system validation?
- What are most frequent recent citations for Part11?
- How important is risk based Part11 compliance?
- Under which circumstances can inspectors exercise enforcement discretion?
FDA`s enforcement of 21 CFR part 11 compliance 2015 is intended for:
- IT Manager and Staff
- Everybody using computers in FDA Regulated Environments
- Regulatory Affairs
- QA Managers and Personnel
- Consultants
- Training Departments
- Validation Specialists