The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
Why You Should Attend: Compliance with process validation requirements results in cost savings and quality product. A robust process that has undergone complete validation provides a high degree of confidence that product will meet specifications. However, medical device professionals continue to struggle with process validation.
Areas Covered In the Seminar:
Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System Validation requirements:
- What is Validation?
- When should it be used?
- How does it differ from verification?
- Validation vs. Verification: Which One?
- Protocol preparation
- Different types of validation
- IQ, OQ, and PQ
- Validation Specialists/Managers
- Process Engineers
- Manufacturing Engineers
- Quality Engineers
- Product/Process Development personnel
- Research and Development personnel
- Quality/Regulatory Personnel