Quality System Design

Quality systems are more than compliance tools—they are strategic assets that protect brand trust, accelerate approvals, and strengthen overall business performance. Built on the world-class Quality Systems of a leading CPG F50 company, Boost’s Quality Systems Design program is grounded in real-world application and proven to deliver stronger compliance, faster qualification, and sustained operational excellence.

This program equips suppliers, contract manufacturers, and quality professionals with practical tools and methods to build and maintain best-in-class systems that enhance audit readiness, consistency, and continuous improvement. Boost helps organizations achieve F50-level quality standards, reduce risk, and safeguard the brands they serve.

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Trainer and Auditor Expertise

All work is led by senior experts who have built and managed real-world quality systems. Boost auditors meet strict professional standards and have experience across multiple industries and regulatory environments.

Certified

Certified in ISO, GMP, GLP, and client-specific systems

Experience

Experience in CPG manufacturing, supplier management, and quality operations

Technical Knowledge

Deep technical knowledge of materials, production processes, and supply networks

Proven Results

Proven results in supplier coaching and CAPA sufficiency

Global

Expertise in global regulatory compliance and continuous improvement system design

Quality

Focus on managing quality investments for both compliance and business value

Quality Systems Design Key Elements

The program includes three connected elements that can be completed sequentially or in parallel,
depending on business needs and risk profile.

Quality System Development

Quality System Development (QSD) Training

to build internal capability

Mock Quality Audits

Mock Quality Audits

to evaluate readiness and identify improvement opportunities

Corrective Action Planning

Corrective Action Planning

using CAPA and SIP frameworks to close gaps and strengthen compliance

Service Offerings

Regional Group Training: 5-Day Basic QSD (Virtual or On-site)

Course Content – 20 Critical Components (formerly 19 QA Key Elements) – Discussion of iQuality Standards and EDANA, including QAP – Tailored exercises and simulations – Certificate of completion – Trainers on-site for personal coaching – Venue options: hotel conference room or your site – If class is at your facility, Pan City (audit simulation) is replaced with an on-site audit led by an experienced auditor.

Regional Group Training: 3-Day Advanced QSD (Virtual or On-site)

Advanced Course Content – Deeper dives on selected topics beyond the 5-Day course – Case studies and practical examples – 6-tab training notebook with updated, in-depth materials – QSD Certificate – Ideal next step after the 5-Day course – Focus areas include: Quality Incident Elimination, avoiding Mislabel/Mispack/Miscode errors, Validation and Change Control, Process Control, Contractor Quality.

Remediation & Coaching (On-site at your facility)

Services – Individual, site-specific Quality Plans – 1–2 hour executive training – Review and improve site-specific Quality Plans for compliance – Mentoring for QA leaders

Audit Consulting: Compliance Assessments (Virtual or On-site)

Services – Co-lead a 2–3 day on-site audit highlighting strengths and gaps for each Key Element – Assess effectiveness of corrective actions to address outages identified in prior audits – Prepare a written SIP report – Co-develop a post-SIP improvement plan and review improvement efforts – Coach the site QA Leader and selected KE Leaders on EDANA QAP requirements – Assess compliance with standards and expectations – Support audit reviews and action-plan development