SOPs for Clinical Trials – Regulatory Requirement and Key to Effective Management 2012

Topics

• Management Responsibilities for the development, maintenance and compliance with SOPs
• ICH-GCP and ISO 14155 requirements for SOPs
• Risk management through the use of SOPs
• Inspection findings related to SOPs
• SOPs samples/templates
• Required features of SOPs
• Benefits of efficient development, maintenance and use of SOPs

Who should Attend

Attendees from Pharma, Biotech and Medical Device companies including Quality Systems managers, General Managers and Directors, Clinical Development and Project managers, Quality Assurance managers and auditors, Regulatory Compliance Associates and Managers, Clinical Team managers, Heads and Members of Ethics Committees/Independent Review Board, Principal Investigators and Trainers.