FDA Regulations for Analytical Instrument Qualification and Validation – Comprehensive Best Practices 2018

Topics

• 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

Who should Attend

• Quality Departments
• Research and Development Departments
• Manufacturing Departments
• Regulatory Affairs Departments
• Operations Departments
• Engineering Departments
• Production Departments