SERVICES Non-Conformance & Deviation Management

    The FDA Group provides specialized consulting services to help life sciences companies establish effective non-conformance and deviation management systems. Our experts guide organizations in developing robust processes for identifying, investigating, and resolving quality events while extracting valuable improvement opportunities. We implement systems that satisfy regulatory requirements while providing meaningful data to drive continuous improvement across your organization.

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    Eliminate backlogs and turn quality events into improvement opportunities

    Effective management of non-conformances and deviations is critical to maintaining product quality and regulatory compliance. Our approach focuses on establishing systematic processes that not only address individual events but also enable trend identification and prevention of recurrence. We help you implement systems that capture appropriate data, drive thorough investigations, and generate meaningful corrective and preventive actions that strengthen your quality system.

    Our non-conformance/deviation management services include, but are certainly not limited to:

    • Backlog Elimination

      Deploy contracted individuals to embed on-site or remotely to eliminate backlogs of quality events.

    • Investigation Support

      Expert guidance for root cause analysis and comprehensive investigations.

    • Process Development

      Creation of compliant, efficient non-conformance and deviation handling procedures.

    • Non-Conformance System Assessment

      Evaluation of existing systems against regulatory requirements and best practices.

    • CAPA Development Assistance

      Support for generating effective corrective and preventive actions.

    • Electronic System Implementation

      Guidance on selecting and implementing electronic non-conformance tracking systems.

    • Trend Analysis Programs

      Development of methodologies to identify patterns and systemic issues.

    • Training & Coaching

      Building internal capability for effective non-conformance management.

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    Engagement Models

     

    Get access to expert consultants and contractors as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

    ENGAGEMENT MODEL Consulting Projects

    Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

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    ENGAGEMENT MODEL Staff Augmentation

    Get contracted full-time consultant/contractor (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

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    Engagement Model FTE Recruitment

    We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

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    Why work with The FDA Group?

     
    • Exclusive life science focus and expertise
    • Dedicated account management team
    • Right resource, first time (95% success)
    • 97% client satisfaction
    • Total Quality Guarantee

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    Our Proven Process

    Introductory Conversation

    • About Us
    • About You
    • Scope Of Work

    Resources Definition

    • Background And Expertise
    • Location Of Resource
    • Rate Rightsizing

    Proprietary Resource Selection Process

    • In-House Subject Matter Experts
    • Recruiting Team External Search
    • Resource Identification

    Resource Presentation

    • CV And Rate
    • Perfect Match Summary
    • Interview Call Coordination

    Agreement Processing

    • MSA And Addendums
    • Supplier Qualification
    • Kickoff Coordination

    Account Management

    • Project Management Of Resource
    • Satisfaction Management For Client
    • Total Quality Guarantee

    Ready to strengthen your quality event management? Contact us and get the conversation started.

    Contact The FDA Group today to discuss how our non-conformance and deviation management services can help you transform quality events into improvement opportunities. Our resources can be utilized to meet the wide range of quality assurance requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


    Fill out and submit the form below to share a few preliminary details and start the conversation. We pride ourselves on our responsiveness and will respond within one business day or less. We also take privacy as seriously as you do. All information is kept secure and confidential.