GMP Cleanroom Consultancy Team

W2 Cleanroom Consulting is led by senior GMP professionals with hands-on experience in NHS aseptic services and commercial sterile manufacturing environments. Our team has supported facilities through cleanroom design, validation lifecycle implementation and regulatory inspection readiness.

We operate as practitioners as well as advisors, combining operational leadership experience with structured GMP consultancy to deliver inspection-defensible outcomes.

Kyle Winn

Director | GMP Consultant

Kyle Winn is a Director at W2 Cleanroom Consulting and a senior leader within NHS sterile manufacturing environments. He has led large-scale aseptic production operations and capital cleanroom developments, with direct responsibility for GMP governance, regulatory compliance and inspection readiness.

His work focuses on Annex 1 (2023) implementation, sterile facility strategy, contamination control integration and lifecycle validation oversight aligned to Annex 15 principles. Kyle brings executive-level understanding of how sterile facilities operate under regulatory scrutiny, ensuring consultancy outputs are both inspection-defensible and operationally deliverable.

He has overseen sterile production teams, governance system design, workflow optimisation and quality framework integration across regulated NHS manufacturing centres. His approach centres on structured risk assessment, capital project assurance and sustainable GMP system implementation within complex healthcare environments.

Areas of Expertise:

• • GMP Facility design review and zoning strategy

• Annex 1 (2023) alignment and implementation

• Cleanroom workflow and material / personnel flow assessment

• Lifecycle validation strategy (DQ, IQ, OQ, PQ)

• Inspection readiness and regulatory governance frameworks

• Operational GMP integration within aseptic services

Connect:
Email: info@w2cleanrooms.com

Adam Walker

Director | Qualified Person (QP) | GMP Consultant

Adam Walker is a Director at W2 Cleanroom Consulting and a Qualified Person (QP) with extensive experience across GMP-regulated sterile manufacturing environments. His expertise spans cleanroom qualification, Validation Master Planning, lifecycle validation strategy and regulatory-aligned commissioning within both NHS and commercial facilities.

Adam has led facility and equipment qualification programmes, including complex aseptic systems and vapour hydrogen peroxide (VHP) isolator testing. His work focuses on Design Qualification governance, traceable DQ/IQ/OQ/PQ frameworks and the implementation of quality systems that support both licensed and unlicensed sterile operations.

He has contributed nationally to aseptic manufacturing development initiatives and provides structured GMP consultancy that translates regulatory requirements into practical, inspection-defensible operational systems.

Areas of Expertise:

• Validation Master Planning and lifecycle validation strategy

• Design Qualification (DQ) governance and commissioning oversight

• Qualification of aseptic systems and barrier technologies (VHP isolators, cleanrooms)

• Sterile GMP quality system design and remediation

• Qualified Person (QP) support and EU GMP compliance

Connect:
Email: info@w2cleanrooms.com

As a team, we bring a unique dual perspective to every project — combining production and quality expertise to deliver compliant, practical solutions for cleanroom and aseptic facilities.

Our shared philosophy is simple:
Compliance should be practical. Quality should be achievable. Teams should feel confident.

Blessing Dina is a validation and quality systems specialist supporting W2 Cleanroom Consulting with computerised systems validation, data integrity strategy, and GMP compliance within regulated pharmaceutical environments.

He brings extensive experience across pharmaceutical manufacturing, distribution, and aseptic production, with a strong focus on ensuring systems, equipment, and processes remain validated throughout their lifecycle. His expertise spans computerised system validation (CSV), regulatory compliance, validation planning, and implementation of Pharmaceutical Quality Systems aligned with EU GMP requirements.

Blessing currently leads computerised system validation activities within a large sterile manufacturing environment, ensuring compliance with EU GMP Annex 11 and Annex 15 while supporting the development and maintenance of validated digital systems that underpin manufacturing, quality control, and product release processes.

He also provides structured support to inspection readiness programmes, regulatory remediation work, and validation governance across regulated pharmaceutical facilities, helping organisations maintain compliant, sustainable, and inspection-defensible systems.

Blessing combines technical validation expertise with a strong understanding of operational GMP environments, enabling him to translate regulatory expectations into practical system controls that support both compliance and operational efficiency.

Areas of Expertise

• Computerised Systems Validation (CSV) and lifecycle system validation

• EU GMP Annex 11 and Annex 15 compliance

• Data Integrity strategy, governance, and risk assessment

• Pharmaceutical Quality System (PQS) implementation and improvement

• Validation planning, protocols, and summary reporting

• GMP inspection readiness and regulatory remediation

• Computerised system user requirements specification development

• Validation Master Planning and system lifecycle management

Connect:

Email: info@w2cleanrooms.com

Blessing (Tayo) Dina

Validation & Computerised Systems Validation (CSV) Specialist | Associate Consultant