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Keith Brennan

Senior IT Validation Specialist

1
Courses
4.68
Rating

Teaches in: Web & Mobile Design

About Me

I've spent the last 16 years working in quality assurance and computerized system validation across pharmaceutical and medical device companies. My career started on the bench in a GMP manufacturing environment, where I quickly realized that the systems we rely on need just as much scrutiny as the products themselves. Over time, I shifted focus to IT validation, and for the past six years, I've been deep in the weeds of mobile application compliance, helping teams figure out how to apply GAMP 5 principles to platforms that were never designed with FDA in mind.

When I teach, I lean heavily on real scenarios I've encountered in audits and remediation projects. I don't sugarcoat how hard this stuff can be, especially when you're dealing with OS updates, intermittent connectivity, and vendor pushback. My goal is to walk you through practical frameworks you can actually use, not just theory that falls apart on the factory floor. Students in my courses leave with validation plans they can adapt to their own environments and a clear understanding of what regulators expect to see.

Featured Courses

Mobile Application Validation in GxP Based on GAMP 5
Web & Mobile Design
Mobile Application Validation in GxP Based on GAMP 5
Master GAMP 5 principles for validating mobile apps in regulated environments. Perfect for QA manag…
4.36
Keith Brennan Learn More

Expertise

GAMP 5 Validation Mobile Application Compliance 21 CFR Part 11 GxP Regulatory Requirements Computerized System Validation (CSV) Risk-Based Validation Data Integrity IQ/OQ/PQ Qualification

Experience

Corteva Pharma Solutions

Lead IT Validation Engineer

Regulus BioScience

Senior QA Systems Analyst

Meridian Device Corp

Validation Specialist II

Pinnacle Therapeutics

Quality Assurance Associate

Achievements

  • Developed and implemented mobile app validation framework adopted across 14 manufacturing sites for a top-20 pharma company
  • Published article on GAMP 5 Category 3/4 classification for mobile apps in the Journal of GXP Compliance (2023)
  • Speaker at ISPE Annual Meeting 2024 on managing continuous validation for mobile platforms in regulated environments
  • Led successful FDA pre-approval inspection (PAI) readiness program covering 22 computerized systems, zero 483 observations
  • Hold ASQ Certified Quality Auditor (CQA) and ISPE Certified CSV Professional credentials
  • Maintains open-source GAMP 5 mobile validation checklist template on GitHub with 800+ stars from industry professionals

Teaching Impact

  • 1 Course
  • 4.68 Average Rating