Learning Objectives:

Upon completing this course participants should:

• Understand what the global expectations are for equipment qualification and validation.
• Understand the documents required for equipment qualification and process validation and how to manage documents appropriately.
• Understand and know how to write and maintain a Validation Master Plan.
• Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
• Qualify already existing systems and requalification
• Be able to collect data, conduct tests, and obtain all necessary documents.
• Understand the different types of validation.
• Understand Performance Validation.
• Know the guidelines on validating analytical methods and processes.
• Support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control.
• Understand and know the principles of auditing the equipment qualification and validation.
• Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier.
• To investigate true root causes of problems and to evaluate and prioritize solutions
• Problem solving methods to help you asses which is best for your situation
• Develop successful implementation plans
• Perform risk assessments effectively