Implementing Validation and Qualification - Annex 15 and FDA Requirements 2016

Topics

• The role of SOPs in the preparation and management of that documentation
• The role of the various documentation
• How to use Quality Management and Risk Management
• The organization of processes and sub-processes
• How to comply with these changes
• The content and format of SOPs
• The responsibilities of the various stakeholders
• The role that each person plays in quality

Who should Attend

• Computer Application and IT Infrastructure Staff
• Quality Assurance Professionals
• Operation managers and staff
• Project Managers who manage the use of the Processes
• Compliance Professionals
• Auditors
• Training departments
• Regulatory affairs
• Consultants
• Documentation department