FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices 2019

Topics

• Major considerations in the regulatory requirements for:
• Unique QSIT Subsystems and assessment process
• Latest GMP regulations for medical devices
• How to lay a strong foundation for fulfilling FDA’s QSR
• Preparing and Executing Audit Proof Quality System
• Recent findings by FDA 483s and more serious warning letters
• Unannounced FDA audit Readiness
• Challenges in maintaining the promises made in your response letter to FDA
• Essential components of a well-documented quality system
• How to perform a risk-based mock QSIT assessment

Who should Attend

• Manufacturing Departments
• A must attend webinar for teams in:
• Research and Development Departments
• Process Engineering
• Quality Assurance Departments
• Design Assurance Departments
• Quality Engineers
• Quality Control Departments
• Sterilization and Production Cleanroom maintenance Teams
• CAPA Coordinators
• Regulatory Departments
• Document Control Departments