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Equipment Validation, Tracking, Calibration and Preventive Maintenance  

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This webinar will provide valuable assistance to all personnel involved in equipment/process development

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Seminar Summary:

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 along with 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. (see full course description)

 

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Training Course Syllabus:


Equipment Validation, Tracking, Calibration and Preventive Maintenance Webinar

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.

Objectives of the Presentation

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

Why Should you Attend

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.

Areas Covered

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

Topic Background

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.

Who will Benefit

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

Seminar Summary:

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 along with 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. (see full course description)

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