This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
It will provide guidance in fulfilling requirements in the statute and parts of FDA’s regulations for maintaining records or submitting designated information electronically.
It will provide guidance in fulfilling requirements in the statute and parts of FDA’s regulations for maintaining records or submitting designated information electronically.
Areas Covered in the seminar:
- Scope and Application
- FDA’s Part 11 Approach
- Validation
- Audit Trail
- Legacy Systems
- Record Copies
- Record Retention
- Enforcement
Who Will Benefit:
This webinar will provide valuable assistance to pharmaceutical, device and biologics regulated companies in or transitioning into a cGMP compliant environment. It is also useful as a refresher for companies that wish to stay current with FDA's expectations for records maintenance and submission. The employees who will benefit include:- Management
- Information Technology Managers
- Quality Units
- Auditors
- Quality Systems Personnel
- Consultants
Course Provider
Betty Jones,
