Headshot of Stephanie Brandford, founder of Brayearst Validation Consulting, specializing in FDA compliance and Six Sigma validation services.
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  • Founder & Validation Consultant

    Greetings!

    I'm Stephanie, a Carnegie Mellon chemical engineering graduate with a fervor for optimization and compliance. My journey commenced in the chemical industry, delving into environmental regulations and harnessing my expertise in statistical process control to enhance manufacturing processes, fostering efficiency and sustainability.

    Venturing into the medical device industry, I carried these principles into the rigorous realm of FDA standards. There, I dedicated myself to ensuring the safety and reliability of life-saving products. Armed with a Six Sigma Black Belt certification, I assumed a leadership role in validation engineering, guiding teams toward maintaining the utmost quality in manufacturing practices.

    Building on my extensive experience, I founded Brayearst Validation Consulting, dedicated to implementing Six Sigma methodologies to provide comprehensive validation services. Within the Life Sciences sector, regulatory compliance requires incontrovertible proof of efficient manufacturing processes. At Brayearst, we combine our deep understanding of products with engineering expertise to create robust validation documentation designed to endure the most stringent auditor examinations. This endeavor marks a significant chapter in my professional journey, reflecting a commitment to excellence and a passion for enhancing industry standards through precision and compliance.

  • Becton Dickinson (BD)

    BioWhittaker, a Cambrex Company (currently Lonza)

    Air Products & Chemicals

  • 2023-10-04 International Society of Pharmaceutical Engineering Chesapeake Bay Area chapter mentor on Validation

    2023-12-08 Unofficial Regulatory Affairs Professionals Society Capital Region study group presenter on Six Sigma

    2024-02-07 Maryland Business Opportunity Center Small Business Showcase exhibitor

    2024-02-22 CoursWorx webinar presenter on Process Validation

    2024-03-08 SBA Baltimore Metropolitan Women's Business Center at Morgan State University Women WIN Within exhibitor

    2024-04-12 Women in Bio panel speaker on Risk Resilience

    2024-04-23 Parenteral Drug Association Capital Area meeting presenter on Process Validation

  • Life Sciences companies with processes requiring validation will have confidence that auditors will read, understand, and accept the conclusions about the process.

    • Sustain and grow revenue with uninterrupted operations.

    • Reduce costs by avoiding audit response investigations.

    • Heighten customer value and perception with good audit outcomes.

    • Build staff expertise with completed packages.

  • Using Six Sigma methodology provides thorough and data supported validation packages.

    Like Six Sigma, Brayearst also uses a structured approach to validation: CAGES℠.

    (C)laims – Expectations for the product and the process making it

    (A)pproach – Validation study structure to prove the claims

    (G)athering (E)vidence – Instructions and training on performing the validation studies and analyzing the data

    (S)ummary – Closure statements about the studies satisfying approach and claims

  • Brayearst Validation Consulting was founded in Maryland in 2023 as Brayearst LLC. It is assigned Dun & Bradstreet D-U-N-S® Number 125667420 and operates under NAICS code 541690 for "Other Scientific and Technical Consulting Services" and 611430 for “Professional and Management Development Training”.

  • Full-time, on-site support is suitable when hiring employees. For tax purposes, Brayearst operates as an independent consulting agency.

    A hybrid of on-site and remote support is available for manufacturing sites in the Mid-Atlantic United States region. Intermittent visits to the facility will be planned as needed for the project.

    Remote support is available for manufacturing sites accessible by rail transportation. An introductory visit to the facility will be planned as needed for the project.

  • flyer.brayearst.com

Inquiry Form

Are you still thinking about how to bring your processes into compliance? Thank you for your consideration in meeting your validation consulting needs with Brayearst.

Please provide your contact information and any details you’d like to share for us to move forward with your project.

Professional hands typing on a laptop keyboard, planning for FDA compliance and Six Sigma validation projects with Brayearst Validation Consulting.

Are you ready to invest in your business to satisfy regulatory requirements?

Once you've sent this form, remember to check your email, including any junk or spam folders, for a follow-up message to prepare for our initial consultation. Looking forward to hearing from you!