Effective Records Management and Document Control for Medical Devices 2019

Topics

• Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate
• Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
• Improving efficiencies over the QMS tasks
• Creating Action Plans, and verifying their effectiveness
• Ensuring compliance to 21 CFR Part 11 and immutable audit trail
• Reducing the risks of manual error
• Taking the resource burden out of creating dashboards/ periodic reports
• Avoid observations, 483 letters and fines

Who should Attend

• Quality Assurance professionals
• Regulatory professionals
• Individuals involved with FDA compliance
• Executive Management