21 CFR Part 11 and Risk Assessment

Topics

• Key Requirements of Part 11
• 21 CFR Part 11 Compliance
• Learning from Recent Warning Letters
• Annex 11
• Achieving Data Integrity
• Computer System Validation
• VMP & Design Specifications
• Meeting Data Integrity Regulations
• Risk Based Validation
• Risk Assessment
• CASE STUDIES ….and More
• SOPs and Best Practices

Who should Attend

• Regulatory Affairs Management and Personnel
• Quality Assurance Management and Personnel
• Operations Management and Personnel
• Research & Development Management and Personnel
• Manufacturing Management and Personnel
• Production Management and Personnel
• Facility and Maintenance Management and Personnel
• Engineering Management and Personnel
• Everyone involved in Product, Process, CAPA Resolution, Failure Investigation Responsibilities