This training on FDA compliant electronic records and signatures will will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.
This 90-minute session will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.
Why Should You Attend:
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency - both efficiency in project management, and avoidance of non-compliance penalties.This 90-minute session will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.
Areas Covered in the Seminar:
- History and Overview.
- Subpart A: General Provisions.
- Subpart B: Electronic Records.
- Subpart C: Electronic Signatures.
- Scope & Application Guidance.
- Questions and Answers.
Who Will Benefit:
- Project/Strategic Management
- Quality Assurance staff
- IT staff
- Operations staff
- For FDA regulated companies, any staff members who may be involved with :
- Computerized system projects
- Validation of those systems, or
- have responsibility for maintenance/security of electronic records.
- Additionally, staff members from companies which may develop software or computer systems for FDA regulated companies.
Course Provider
Harry Huss,
