What I do
Six services. One standard: inspection-ready, every time.
Each engagement draws on 25 years spent building, running, and auditing quality and validation systems inside pharmaceutical, biopharmaceutical, and vaccine manufacturing — not just consulting on them from a distance.
QMS Design & Implementation
Building a Quality Management System from the ground up — Quality Manual through SOPs — aligned to GMP, ICH Q10, and ISO 9001:2015.
- Quality Manual and Quality Policy
- Site Master File (SMF)
- Tier I–III document architecture (Quality Manual → SOPs → BMR / BPR / work instructions)
QMS Audit & Review
Independent, line-by-line review of an operating QMS — so weaknesses surface on your terms, not a regulator's.
- Document-by-document QMS review report
- CAPA effectiveness and closure-quality review
- Deviation and change-control trend analysis
Gap Analysis & Audit Readiness
A dry run of your next regulatory inspection — mock audit, documentation review, and shop-floor walkthrough — so findings surface before the real one.
- Mock inspection in the style of your target authority (USFDA / WHO / EU-GMP / CDSCO)
- Facility and documentation gap report, classified critical / major / minor
- CAPA plan with owners and realistic timelines
CQV Documentation
Apex-level CQV governance through to execution — Master Plans, risk assessments, and URS-through-PQ protocols for facilities, utilities, equipment, and computerized systems.
- CQV Master Plan (CQVMP)
- System Level Impact Assessments (SLIA) and Quality Risk Assessments (QRA)
- URS, Design Qualification (DQ), FAT and SAT protocols
GMP Training
Structured, role-specific GMP training — from shop-floor operators to quality leadership — built around real deviations, not generic slide decks.
- Training needs assessment by role and function
- Role-based curriculum: operators, QA/QC, engineering, and management
- Classroom, on-site, or virtual workshop delivery
GMP Lectures
Focused, single-session lectures and webinars on GMP, QMS, or CQV topics — for conferences, internal quality forums, or academic programs.
- A custom lecture on a chosen topic — e.g. CAPA effectiveness, data integrity, CQV fundamentals, technology transfer, or audit readiness
- In-person or virtual delivery
- Q&A or panel participation
Let’s talk
Not sure which service fits your situation?
Tell me what you're working with — a facility, an upcoming inspection, a QMS that's fallen behind — and I'll recommend where to start.