This session will review the regulatory requirements for validation, including detailed review of IQ, OQ, and PQ. A sample validation process will be followed through each phase. Documentation requirements for both protocol and results will be reviewed, as well as a list of pitfalls to avoid in documenting your validation. The importance of the Master Validation Plan will be discussed too. Preventive maintenance will be covered, including how to assure it does not adversely impact validated processes. A cost-effective equipment calibration program will be featured as well.
Objectives of the Presentation
Why Should you Attend
- Types of Validation
- The Validation Sequence
- Calibration Frequency and How to Reduce It
- Understanding of Calibration Traceability
- Benefits of Equipment Calibration Outsourcing
- Calibration Remediation Requirements
Medical devices and pharmaceutical products must be safe and effective. Equipment used in assembly, test, or measurement must be able to be used for its intended purpose, and result in product that meets its required specifications. It is not cost effective to routinely measure product to evaluate conformance to all specifications. It is, therefore, critical to have an in depth understanding of the methods for establishing equipment and corresponding processes that assure product output on a routine basis.
Who will Benefit
- Equipment Validation
- Installation Qualification
- Operation Qualification
- Performance Qualification
- Equipment Calibration
- Use of Calibration Standards for Efficiency and Accuracy
- Remedial Action for Out-of-Calibration Equipment
- Calibration vs. Maintenance: Which One?
- Equipment Maintenance
This webinar will provide valuable assistance to all personnel involved in equipment/process development:
- QA management
- Quality Engineering staff
- R&D management
- Engineering management
- Production management
- Manufacturing Engineering staff
- Design engineers
- Reliability engineers
- Calibration technicians
- Maintenance personnel
Validation is a systematic approach where data is collected and analyzed to confirm that a process will operate within the specified parameters whenever required and that it will produce consistent results within the predetermined specifications. The process verifies if the compliance and quality standards are being met by a product in real time. In a pharmaceutical facility, the validation program establishes that a company is meeting current good manufacturing process (cGMP) guidelines that are set for the industry by concerned regulatory bodies. In short, validation can be considered as documented evidence that the process is meeting the predetermined specifications.
Validation is concerned mainly with processes. When the same approach is applied to a machine or any equipment instead of a process, it is referred to as qualification instead. Qualification is not limited to a validation process, but it is a part of it. It can be further divided into installation qualification (IQ), operation qualification (OQ) or performance qualification (PQ).
Calibration determines if a device or instrument is producing accurate results within the specified limits compared to those produced by a traceable standard over an appropriate range of measurements. Calibration is crucial for justifying qualification and validation. An accredited laboratory can ensure that all the calibration services and activities are performed with qualified instruments.