FDA Regulations for Analytical Instrument Qualification and Validation Comprehensive Best Practices 2018 is a webinar that covers topics such as:
- Understand and know how to write and maintain a Validation Master Plan
- Understand the documents required for equipment qualification and process validation and how to manage documents appropriately
- Qualify already existing systems and requalification
- Be able to write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
- Understand the different types of validation
- Be able to collect data, conduct tests, and obtain all necessary documents
- Know the guidelines on validating analytical methods and processes
- Understand Performance Validation
- Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier
- Be able to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
- Perform risk assessments effectively
- Develop successful implementation plans
FDA Regulations for Analytical Instrument Qualification and Validation Comprehensive Best Practices 2018 is intended for:
- Quality Departments
- Research and Development Departments
- Manufacturing Departments
- Regulatory Affairs Departments
- Operations Departments
- Engineering Departments
- Production Departments
