Equipment Validation, Tracking, Calibration and Preventive Maintenance
About This Event
Description
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.
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.
For Registration
https://www.onlinecompliancepanel.com/webinar/VALIDATION-TRACKING-CALIBRATION-502844/AUGUST-2016-ES-WORLDCONCAL
Note: Use Promo code HY4LZ and get 10% off on registration (Valid till JUNE 30th 2017)