Stephen Brown

Senior Consultant, GxPAssure

Stephen Brown is an accomplished regulatory and quality professional with extensive experience in pharmaceutical and medical device compliance, including distinguished tenure with the U.S. FDA. Specialising in cGMP inspections, audit readiness, and regulatory strategy for sterile, biological, and pharmaceutical manufacturing environments. Stephen is known for identifying compliance gaps, leading high-impact domestic and international inspections, and guiding organisations through effective remediation and sustained compliance. His expertise spans aseptic processing, active pharmaceutical ingredients (APIs), vaccines, 503A/503B compounding pharmacies, medical devices, and data integrity. Recognised for clear, objective reporting, Stephen also brings strong training, coaching, and cross-functional collaboration skills to help teams translate regulatory expectations into practical, measurable improvements.

His core expertise;

• FDA inspection readiness, including mock inspections and support during regulatory interactions
• CGMP compliance programmes, gap assessments, and audit readiness aligned to FDA and ICH expectations
• Aseptic processing and sterile manufacturing oversight, including contamination control expectations
• Quality systems: deviations, investigations, CAPA, change control, and risk management
• Data integrity (ALCOA+), documentation practices, and technical/quality writing
• Vendor/supplier auditing, qualification support, and quality agreements
• Coaching and training for cross-functional teams and investigators
• Aseptic processing and sterile manufacturing oversight, including contamination control expectations
• Quality systems: deviations, investigations, CAPA, change control, and risk management
• Data integrity (ALCOA+), documentation practices, and technical writing
• Vendor/supplier auditing and quality agreement support
• Coaching and training for cross-functional teams and investigators management and inspection execution.
• Supported remediation following regulatory actions (e.g., FDA Form 483 observations and Warning Letters), including readiness checks and effectiveness verification.