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11 Free Resources to Boost Your FDA Readiness

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Toolkit Videos 1 1 FDA Readiness Toolkit Quality standards are defined by governing entities in order to promote and sustain the quality of products manufactured throughout the world. The guidelines set forth by regulatory agencies like the FDA are a major factor in ensuring that companies manufacture and sell products that are safe, reliable, and effective. Complying with these regulatory requirements is simply a part of doing business for many organizations. MasterControl, a global provider of enterprise quality management software (EQMS), has invested over 380 expert hours into the creation of this FDA Readiness Toolkit designed to help companies like yours simplify compliance with FDA standards by streamlining quality-related processes. FDA Just Called! Now What? Regulatory gurus Linda Chatwin and Walt Murray explain what needs to be done to maintain a continual state of regulatory readiness. They walk through the steps that should be taken when the FDA schedules an inspection, and even what to do when inspectors show up unannounced. Passing Audits and Inspections wih MasterConrol MasterControl customers tell how the solution simplifies audit processes, impresses auditors, relieves audit concerns, and gives them a competitive edge. How a Med Dev Company Uses the MasterControl EQMS Learn how ReliantHeart, a medical device company, utilizes the MasterControl Training™ solution to avoid training issues that can lead to non-compliance with FDA regulations. According to ReliantHeart's Chief Operating Officer (COO), Anthony Williams, "MasterControl is known by the FDA and that's a huge advantage."

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