Process Validation - Overview of Why and How

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.

Why Should You Attend:

Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate risk properly, you may face enforcement actions such as fines or recalls. However, too much validation is costly in both time and money.

This webinar will cover the basics of this important topic for those who are new to quality or new to process validation. It will:

• Cover the requirements for process validation from FDA cGMP and ISO 13485.
• Discuss when process validation and revalidation are necessary or desirable.
• Provide an outline of equipment qualification.
• Provide an overview of what is required for process validation.

Learning Objectives:

• Learn why process validation is necessary
• Understand what process validation is
• Learn about process validation guidelines
• Understand when to validate processes and what processes to validate
• Understand how to do process validation

Areas Covered in the Webinar:

• What is process validation
• Why is process validation necessary
• Process validation guidelines
• How to determine if a process requires validation
• What processes should be validated
• Process validation outline
• IQ - Installation Qualification
• OQ - Operational Qualification
• PQ - Performance Qualification
• Process monitoring

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Engineering
• Manufacturing engineers
• Internal auditing
• Compliance
• Others in Quality
• Quality Managers new to medical devices or process validation
• Operations/Manufacturing Managers new to medical devices or process validation
• Medical device consultants new to process validation