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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 began in the chemical industry, where I delved into environmental regulations and used statistical process control to enhance manufacturing processes, fostering efficiency and sustainability.

    In the medical device industry, I applied these principles within the rigorous realm of FDA standards, 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, where I not only guided teams to maintain manufacturing quality but also conducted peer reviews of validation packages for compliance and improvement—a practice I've refined over the past decade. Additionally, I’ve spent 12 years designing and delivering training programs, empowering professionals to excel in validation and Six Sigma methodologies.

    Building on this expertise, I founded Brayearst Validation Consulting, which offers validation projects, training, and spot check services. We help Life Sciences companies meet regulatory requirements with robust validation documentation that withstands auditor scrutiny. This reflects my commitment to precision, compliance, and elevating industry standards.

  • Brayearst Validation Consulting

    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

    2024-07-17 Baltimore County Public Library's Small Business Pitch Competition

  • 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 codes 541614 for "Process, Physical Distribution, and Logistics Consulting Services", 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.

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!