Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 unique Read more
This session will review the regulatory requirements for validation, including
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must
Course Objectives:
• 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
Course Outline:
• Equipment Validation
o Installation Qualification
o Operation Qualification
o 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
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