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?

Course Objectives:

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.

Course Outline:

Attend this interactive webinar, and you will:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This course will be of benefit to anyone involved in the equipment qualification and validation process. Those in the following functional areas will find this course particularly useful:

• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Quality control unit directors and staff
• Consultants
• IT managers and staff
• Laboratory managers, supervisors and analysts