Brayearst Validation Consulting

Name: Brayearst Validation Consulting
Address: Pikesville, MD, 21208, US
Telephone: +14432480350

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Brayearst Validation Consulting

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We strengthen life sciences validation through customized training and document reviews, using our proprietary CAGES® Framework.

Audit‑ready, team‑equipped, FDA‑compliant. Brayearst Validation Consulting applies the trademarked CAGES® Framework to deliver targeted validation training and spot‑check reviews for life sciences companies. With decades of engineering and FDA compliance experience, we help teams build internal capability and audit‑ready documentation across process, cleaning, software, test‑method, and contamination‑control validation. Founder & CAGES® Framework Steward: Stephanie Brandford

11/09/2026

Many professionals equate a completed cleaning with clean equipment. On shared manufacturing equipment, the difference matters: residue that survives cleaning can carry into the next product, batch after batch. Professionals in Operations, Quality, and Validation roles all influence whether cleaning works, and understanding what cleaning validation demonstrates helps them recognize a cleaning gap early. Our new blog post explains the principle through an FDA warning letter finding, in plain terms. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

11/09/2026

Stephanie Brandford of Brayearst will attend the Big Idea CONNECTpreneur Baltimore Forum on Thursday, November 12, from 8:00 AM to 12:00 PM at the Johns Hopkins Carey Business School (100 International Drive, Baltimore). The forum includes a Rocket Pitch showcase of 8 to 12 emerging tech companies, an investor spotlight, and an early stage investor panel, before an audience with 75+ angels, private investors, and family offices. Attendees are invited to consider which early stage investment trends the panel will cover.

Register here: https://www.eventbrite.com/e/big-idea-connectpreneur-baltimore-forum-nov-12-in-person-tickets-1991799132824.

11/09/2026

Shared equipment is permitted, provided cleaning prevents contamination between products. Under 21 CFR 211.67(a), equipment must be cleaned, maintained, and sanitized at appropriate intervals to prevent contamination. In one FDA warning letter finding, residue on cleaned equipment and carryover into later batches led the FDA to cite the manufacturer, and its response was judged inadequate for lacking a clear analysis of the root cause. Our new blog post walks through what the finding documents. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

11/06/2026

Residue in an exhaust duct says something about every surface. Exhaust ducts are usually waste pathways rather than routes product takes to sale, so residue found there may not explain carryover directly. It does show that cleaning is not removing residue as intended, and the surfaces that contact product deserve the same scrutiny. Our new blog post examines an FDA warning letter finding on shared equipment and what a cleaning validation strategy would examine first. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

11/06/2026

Stephanie Brandford of Brayearst will attend the ATHENAPowerLink Baltimore Women in Business Speaker Series: Women in Media Panel on Tuesday, November 10, from 8:30 to 10:30 AM at the StarTUp at the Armory (307 Washington Ave, Towson). Towson University hosts the session with sponsorship from PNC Bank, and Laura Gamble of PNC of Greater Maryland facilitates. Breakfast and coffee are provided, and the panelists will discuss the accomplishments and obstacles they have encountered as women leading businesses.

Register here: https://towson.my.salesforce-sites.com/events/targetX_eventsb__events #/esr?eid=a0KUJ00000q7v222AA.

11/06/2026

Unidentified chromatographic peaks in later batches demand a clear explanation. When reserve sample testing shows active ingredients from earlier products in later batches, the investigation has to establish how the residue got there. In one FDA warning letter finding, roughly one in ten tested batches showed unidentified peaks consistent with residue from earlier products, and the FDA described the firm's explanations as equivocal. Our new blog post explains why an investigation without a cleaning risk baseline struggles to reach a root cause. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

11/05/2026

Adding a product to shared equipment adds a cleaning risk. Each product introduced to non-dedicated equipment changes what the cleaning must remove and how difficult it is to remove. When the cleaning risk is not assessed until after manufacturing begins, the project inherits the possibility of carryover into later batches, along with the investigations and delays that follow. Our new blog post examines an FDA warning letter finding on shared equipment cleaning and where the gap began. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

11/05/2026

On Monday, November 9, Stephanie Brandford of Brayearst will attend the Governor's Small Business Outreach Summit 2026 at Live! Casino & Hotel Maryland (7002 Arundel Mills Circle, Severn), from 11:00 AM to 4:15 PM. The Maryland Governor's Office of Small, Minority & Women Business Affairs hosts the annual gathering, which links small, minority, women, and veteran-owned businesses with state agencies and prime contractors. Business owners are invited to share which agencies they are targeting for procurement opportunities.

Register here: https://web.cvent.com/event/3d94002d-100e-4ae7-af77-20e90dacdea1/register.

11/04/2026

On Thursday, November 5, Stephanie Brandford of Brayearst will attend the 17th Annual Fort Detrick Alliance x FITCI Tech Showcase from 4:30 to 8:00 PM at the Frederick Innovative Technology Center (321 Ballenger Center Drive, Suite 125, Frederick). The evening is open to scientists, entrepreneurs, creators, students, and business leaders. She expects the opening expo, with its lab tours and exhibits, to prompt useful exchanges with the innovators on site.

Register here: https://www.eventbrite.com/e/17th-annual-fort-detrick-alliance-x-fitci-tech-showcase-tickets-2001381042574.

11/04/2026

A completed cleaning record does not prove the equipment is clean. On shared equipment, every changeover depends on cleaning steps performed the same way each time, including in areas few people think of as product pathways, such as exhaust ducts. When residue survives cleaning anywhere in the equipment, it is evidence the cleaning is not working as intended. Our new blog post walks through an FDA warning letter finding in which residue remained on shared equipment after cleaning, and what it signaled. https://www.brayearst.com/validation-griot/cleaned-is-not-clean-enough

Address

Pikesville, MD
21208

Telephone

+14432480350

Website

https://www.brayearst.com/

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