Equipment Maintenance Calibration and Cleaning - Webinar CD/Transcript
Equipment Maintenance Calibration and Cleaning: Often Overlooked, Never Forgotten
The FDA’s newest crop of inspectors — many of them recently hired from industry — are focusing on equipment maintenance, calibration and cleaning. And they know where to look for problems and what probing questions to ask during inspections.
Having been in the trenches, they know where manufacturers are slacking and they’re hot on the trail of basic GMP violations.
Are your equipment maintenance, calibration and cleaning programs FDA-ready? Are you sure?
As a regulatory requirement, preventive maintenance, calibration and cleaning programs are what help assure that the validated state of equipment utilities and systems remain in a state of control.
But for your state of control to pass FDA muster — during every production shift — you’ll need to understand that the establishment of operational limits are impacted by the successful implementation of such programs and, if not properly maintained, will adversely impact the final quality results.
Specialist Jerry Dalfors — an industry veteran with more than 40 years’ experience, who’s been chosen by the FDA to train their own field inspectors, and whose work has never received a 483 — will share all the details you need for an effective equipment maintenance, calibration and cleaning program plan that works.
Specifically You Will Learn:
- What your written maintenance plan is required by law to contain
- The specific types of things ex-industry inspectors are finding — i.e. fluid levels, worn washers and fittings, leaky pipes, etc.
- How to combat a “fix it and forget it” mentality and how to assure the little things get monitored after plans are implemented
- Why operational limits should be set by observation, not regulation