Stephanie Brandford, Founder & Validation Consultant

Greetings!

I'm Stephanie, a Carnegie Mellon-trained chemical engineer who turned decades of industry experience into a purpose-driven consulting practice. With over 30 years of industry experience, including leading validation teams in the medical device sector and designing business unit-level training programs, I created Brayearst Validation Consulting to help life science companies strengthen their validation capabilities and compliance confidence. My career highlights also include:

• Certification as a Six Sigma Black Belt

• Extensive FDA, customer, and internal regulatory audit experience

• Management of a 19-site global validation leadership council

• Designing and delivering professional training programs for over 12 years

Brayearst was born from a dual passion: precision in process execution and empowerment through education. My time at Becton Dickinson (BD) included two roles that now shape the foundation of our services. As a Quality Engineering Manager, I led validation projects at the site level. As a Validation Program Manager, I supported 19 global facilities, trained validation leaders, and conducted document reviews to maintain corporate standards.

This blend of direct execution and business unit-wide oversight is what makes Brayearst different. While our roots lie in completing validation projects, we’ve evolved to focus on training, documentation reviews ("spot checks"), and capability building to help teams succeed from within. Today, project work supports those goals rather than defines them.

Brayearst uses a proprietary framework for validation that mirrors Six Sigma’s structured logic while being tailored for regulated environments:

Claims – Define expectations for the product and its manufacturing process

Approach – Develop study structures to prove those claims

G/E (Gathering Evidence) – Create and execute instructions, and then analyze study data

Summary – Confirm studies satisfy both approach and claims

We partner with FDA-regulated companies in pharmaceuticals, biologics, and medical devices, especially those who:

• Want to build internal validation expertise

• Need expert review of draft protocols or legacy documents

• Seek supplemental support for specific projects

• Value structured, data-informed methods

We offer remote, hybrid, and occasional on-site support:

• Hybrid support available for facilities in the Mid-Atlantic US

• Remote services nationwide (with travel by rail as needed)

• On-site support for strategic visits or integrated project needs

Brayearst Validation Consulting was founded in 2023 and is headquartered in Maryland.

• Certified as an MBE, WBE, DBE by the Maryland Department of Transportation and the City of Baltimore

• Certified EDWOSB by the U.S. Small Business Administration

• DUNS®: 125667420

• NAICS: 541614, 541690, 611430

We're always open to conversations about improving validation outcomes. You can follow Stephanie on LinkedIn at founder.brayearst.com or schedule a meeting directly at meet.brayearst.com.

Let’s build strong, sustainable validation practices together.