FDA Quality System Inspection Technique (QSIT) Audits Good Preparation Practices 2019 is a webinar that covers topics such as:
- 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
FDA Quality System Inspection Technique (QSIT) Audits Good Preparation Practices 2019 is intended for:
- 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
