Senior-level technical consultancy for regulated industries — delivered with precision, pragmatism, and 35 years of hard-won expertise.
Validation
Rigorous, audit-ready validation is the foundation of every compliant facility. I provide full lifecycle validation support — from strategy through execution to final sign-off — ensuring your systems, equipment and processes meet the standards demanded by global regulators.
What I deliver
- Validation Master Plans (VMP) and Validation Summary Reports
- User Requirement Specifications (URS)
- Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
- Computer System Validation (CSV) aligned with GAMP 5
- Cleaning validation protocols and reports
- Revalidation and periodic review programmes
I work to FDA (21 CFR Part 11), EU GMP Annex 11, EMA, and MHRA standards, and have validated everything from autoclaves, HPLCs, and CIP skids to cleanrooms, filling lines, and laboratory information management systems (LIMS).
The result: documentation that stands up to the most demanding regulatory inspections — first time.
Project Engineering
From initial concept through commissioning and handover, I provide experienced project engineering leadership for capital investment programmes and process improvement initiatives in regulated environments.
I have led projects ranging from £2.5M capital installations to lean process upgrades, working across pharmaceutical manufacturing, biotech facilities, medical device production, and nuclear processing sites.
What I deliver
- Project scoping, planning and scheduling
- Cross-functional team leadership and contractor management
- Equipment selection, procurement support and vendor management
- FAT/SAT coordination and commissioning oversight
- Handover documentation and operational readiness reviews
- Training development and knowledge transfer
I am equally comfortable as the sole technical lead on a focused project or as a senior member of a larger programme team. My Chemical Engineering background means I speak the language of both the engineering and quality functions — bridging the gap that too often causes delays and rework.
The result: projects delivered on time, within budget, and ready for operation from day one.
Quality & Compliance
Regulatory scrutiny is intensifying across every sector I work in. I provide practical, experienced quality and compliance support that goes beyond documentation — building systems and cultures that are genuinely inspection-ready.
What I deliver
- Root cause analysis (RCA) and CAPA development
- Deviation and non-conformance investigation
- Internal and supplier audits
- Inspection preparation and support (FDA, MHRA, EMA, Notified Bodies)
- Standard Operating Procedure (SOP) writing, review and rationalisation
- Quality Management System (QMS) gap analysis and improvement
- Change control management
I have supported clients through regulatory inspections at sites across the UK and Europe, and understand what inspectors look for — and how to ensure your team is prepared, confident, and well-documented.
The result: a compliance posture that protects your licence to operate and your reputation.
Engagement Model
I work on a freelance contract basis, available for:
- Short-term projects — focused documentation, audit preparation, or specific qualification activities
- Long-term embedded contracts — on-site integration with your team for major programmes or ongoing compliance support
- Remote support — protocol writing, document review, and technical advisory from the UK
- Training & knowledge transfer — upskilling your in-house team alongside project delivery
I am based in the UK and regularly work on-site across Ireland, the Netherlands, Belgium, Germany, France, Denmark and Switzerland. I am available at short notice and can mobilise quickly for urgent engagements.
To discuss your requirements:
📧 david@ferencardi.co.uk
📱 +44 7955 767396