21 CFR Part 11 Electronic Records: Electronic Signatures 2013

Topics

• Discussion of key requirements
• Detailed review of 21CFR Part 11
• How does an organization assure their systems are compliant
• How should an organization decide which systems fall under this Regulation
• What are FDA Investigators looking for to asses compliance
• What written procedures and training are required

Who should Attend

• Regulatory Managers/Personnel
• Quality Assurance Managers/Personnel
• IT personnel
• Manufacturing managers, supervisors & personnel
• Senior management executives (CEO, COO, CFO, etc.)
• Internal Auditors
• Documentation
• Project Managers