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

The US Food and Drug Administration (FDA) expect that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. FDA’s findings of deficiencies concerning equipment validation indicate the agency expects definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate a wide range of deficiencies, and compliance is a moving target.

As with most regulatory challenges, the cost of non-compliance is therefore more than that of compliance.  Are you in compliance with the FDA regulations for equipment qualification and validation in your manufacturing facility?

In this 90-minute course, you will learn FDA and other global health authority expectations for equipment qualification, along with the development of a sound process validation program, which will allow you to develop and implement bullet-proof solutions that are accepted, effective, and efficient.

Areas Covered in the Session :

• 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
• Be able to 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
• Be able to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
• Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier
• Develop successful implementation plans
• Perform risk assessments effectively

Who Should Attend:

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