Equipment Validation, Tracking, Calibration and Preventive Maintenance

Duration: 60 Minutes
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.
Validation, Calibration Traceability and Maintenance Equipment
Instructor: Jeff Kasoff
Product ID: 502844
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
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
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.
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Instructor Profile:
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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