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    • A Step-by-Step Guide to Quality System Remediation

    When a gap analysis is effectively performed, it is like taking a trip through your quality system. You know where you want to go, but you need a guide to show you where you are now and what steps you need to take to reach your destination.
    Sometimes the gaps are simple and the itinerary is short. At other times, these gaps point to more complex problems, calling for additional work to reach resolution. Identifying and characterizing these gaps provides quality teams with the information they need to develop and implement a plan for their safe remediation.
    In this article, Larry Stevens presents a step-by-step guide to ensuring that each action included in your quality system remediation plan accurately captures the extent of gaps and establishes a plan to completely fill them.
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    Author

    Larry Stevens

    Larry Stevens has held almost every field position within the FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.

    See also

    SoftExpert EQM
    SoftExpert Risk
    SoftExpert Action Plan
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