Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012 is a webinar that covers topics such as:
- How FDA inspectors check integrity and security of data
- Eight key FDA/EU requirements for integrity and security of electronic data
- The importance of limited access to `individual users` rather than to groups
- Most frequent security and integrity issues: going through recent 483`s, EIRs and warning letters?
- Critical integrity and security issues during the entire life of data: from data acquisition through evaluation to archiving
- FDA compliant definition, acquisition, maintenance and archiving of raw data
- Documenting changes of data: paper, hybrid systems, electronic
- Examples how to ensure and document data integrity
- Review of electronic audit trail: who, what, when and how
- The importance of electronic audit trail to document data integrity
- Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
- Ensuring timely availability through validated back-up and archiving
Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012 brings together:
- QA Managers and Personnel
- IT Managers and System Administrators
- Regulatory Affairs
- QC and Lab Managers
- Documentation Department
- Training Departments
- Consultants