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Subscribe NewsletterRegulatory Requirements for Process Validation and their Protocols for Medical Devices
Product Id
:
600164
Overview: It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation.
Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, "un-automated" processes. This webinar will set forth the regulatory requirements for process validation, and will also include 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.
Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, "un-automated" processes. This webinar will set forth the regulatory requirements for process validation, and will also include 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.
Areas Covered in the Session:
- 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
Who Will Benefit: This webinar will provide valuable assistance to all companies that incorporate processes into their manufacturing, testing, or inspection processes. The employees who will benefit include:
- R&D Personnel and Management
- Process and Quality Engineers
- QA Management
- Regulatory Management
- Consultants
- Quality System Auditors