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

FDA Regulations for Analytical Instrument Qualification and Validation – Comprehensive Best Practices 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 is intended for:

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

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