Live Webinar Equipment Validation, Tracking, Calibration and Preventive Maintenance

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins Live Webinar

"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment

Description

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.

Areas Covered

•    Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification
•    Preventive Maintenance Requirements
•    Calibration vs. Maintenance: When to use Which One?
•    Remedial Action for Out-of-Calibration Equipment
•    Use of Calibration Standards to Save Cost
•    Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation

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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE 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 start-up 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.

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