Improving quality and compliance in the life science industry

Conducting Investigations

Understanding how to conduct a thorough, timely, well-documented and scientifically defensible investigation is a key requirement for any organization operating in a regulated industry. Conducting investigations and root cause analysis provide a structured problem solving process used to locate and address core causes rather than act upon symptoms.

Our Investigations solutions show you how to effectively conduct quality investigations using proven root cause analysis tools and techniques that can be applied to an array of investigation subsets.

SUBSETS

    Complaints
    Non-Conformance Investigations
    Deviations
    Out-of-Specification Investigations (OOS)
    Environmental Monitoring Investigation Reports (EMIR)
    Utility Investigation Reports (UIR)

Training

PathWise focuses on a solution-based approach to solving client issues. When training is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.

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Consulting

Whether it is remediation resulting from regulatory findings, (Form 483 or Warning Letter) or the objective is to improve quality and compliance before that happens, PathWise will work with your organization to deliver solutions. Our consultants go beyond prescriptive suggestions- we work in tandem with clients to create new systems or write new procedures.

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FDA, CAPA & Regulatory Compliance Training

Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.

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