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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:
Jerry Dalfors has 40-plus years of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multi-million dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered an expert in almost all aspects of the biopharmaceutical and medical device industry, and has trained many FDA field inspectors. None of his work has ever received a 483, but he has corrected and prevented many, along with Warning Letter remediation.
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