The FDA’s newest crop of inspectors — many of them recently hired from the 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 Kenneth Christie — an industry veteran with more than 25 years’ experience, who’s worked with giants like Parke‑Davis and Wyeth Laboratories — shares all the details you need for an effective equipment maintenance, calibration and cleaning program plan that works.
With Mr. Christie as your guide, you will complete this transcript and cd recording of our Jan. 30, 2013 webinar with all you need to successfully:
Mr. Christie received rave reviews from prior FDAnews presentations, including:
“Very good presentation content – he understands the topics.”
“Speaker was easy to understand and easy to follow.”
“Information was presented with supporting standards, which is a great way to do it. The presentation gave specifics on monitoring areas that related to what the industry is doing.”
Everyone in your organization with a role in equipment validation plans needs to take part in this 90-minute training session — and they can do so at a cost that won’t break the budget. You pay a single fee per facility, regardless of how many participate. So spread the word.If you’re a drug, device or contract manufacturer you simply can’t afford to miss, Equipment Maintenance, Calibration and Cleaning Programs: Often Overlooked, but Never Forgotten.
Kenneth Christie is the COO of Consulting Services at VTS Consultants, Inc., and has more than 25 years of experience in the areas of manufacturing of sterile products, quality assurance and validation management. Prior to becoming the Chief Operating Officer for VTS, Mr. Christie spent 13 years with the Parke-Davis Sterile Products Division of Warner-Lambert where he served as manager of the Validation Department for eight years. His main responsibilities were management of all validation activities associated with the plant's equipment, utilities, computer control systems and third-party biotechnology companies. Mr. Christie also managed contracted validation personnel and defended all corporate validation practices to regulatory agencies, such as CBER, CDER and the United Kingdom's MHRA Division.
Mr. Christie also spent seven years working for Wyeth Laboratories’ Sterile Biological Vaccines Division of American Home Products as a manufacturing supervisor. Mr. Christie is an active speaker and trainer for several professional organizations. In the international arena, he has provided pre-FDA audit inspections for foreign firms and has authored articles on the challenges of aseptic processing. In his current position, Mr. Christie is a trainer of numerous GxP-related topics, provides regulatory consulting and commissioning services, and helps develop corporate business plans. Mr. Christie possesses a B.S. degree in biology with a chemistry minor and holds an executive master’s degree in business administration from Michigan State University.
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