Process Validation (101) in ISO 9001/Quality/Risk Management

Become Expert in Process Validation techniques for quality & risk management, process control, six sigma, ISO 9001, etc.

Created by: Marco CATANOSSI
Top 10% Instructor - MSc -CEng - Senior Consultant

What Will I Learn?

• Understand and apply the state of the art technique on process validation.
• Understand when it is necessary, convenient or just an option, to validate a process.
• Create a User Requirement Document.
• Create a Master Validation Plan.
• Create a Validation Protocol.
• Perform the Equipment Qualification.
• Perform the Istallation Qualification.
• Performe the Operational and Performance Qualification.
• Know when and how to use the retrospective validation.
• Know when re-validate a process.
• Better understand the requirements of ISO 9001 or Six Sigma with respect to process validation or process control.
• Be employed in positions of responsibilities in companies with processes that need validation.
• Be employed in positions of responsibilities in companies with mass production.
• Be employed in positions of responsibilities in companies working in regulated fields like aerospace, automotive, pharmaceutical, food, and medical industries.

Requirements

• Know what a Gaussian distribution is.
• No particular knoledge, but passion to learn. The course is for beginners.

Target audience

• Managers in production industries
• Quality Assurance or Quality Control professionals
• Quality Engineers
• Production Engineers
• Entrepreneurs
• Process Engineers
• Consultants
• Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries
• Regulatory Affairs managers and engineers
• Professional engaged in ISO 9001 or Six Sigma
• Students and people who want to develop their career in one or more of the fields above