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Certified Lean Six Sigma, AI instructor Exceptional catalyst and change agent Relentless Change management supporter

Experience LS Cube

4 Chapters · 54 Lessons

  1. 1

    Introduction

    1. (Included in full purchase)

      Copyrighted content

    2. (Included in full purchase)

      Overview of Training content and Certification

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      Terminology

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      Lean Six Sigma Body of knowledge

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      Drug Discovery and Development Value Stream

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      Key points in the drug development process

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      Basics of Small molecule drugs and manufacturing them

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      Basics of Biologics - Development and manufacturing

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      Role of Quality throughout the product development cycle

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      Ethical and Regulatory Aspects

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      Opportunities to improve planning and execution of Clinical Research

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      Documentation cycle time pinch points

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      Communication in Regulatory and Clinical Research

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      Change Management in regulated environments

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      Qualitative Research Design and Methods

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      Quantitative Research Design and Methods

  2. 2

    Level 1 — Practitioner (Execution Layer)

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      Black Belts, QA investigators, Compliance specialists

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      Principles and Concepts of Innovation

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      Decision errors in LSS/QA systems

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      AEL Classification Engine

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      FACT / DATA / INTERPRETATION / ASSUMPTION

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      Deviation scenario walkthroughs

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      Why AI breaks traditional workflows

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      Approving AI-supported decisions in regulated environments

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      Hidden assumptions

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      Blocking assumption-driven decisions

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      Deviation Investigation System

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      IS / IS NOT + AEL

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      Hypothesis discipline

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      Evidence gap detection

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      Decision Gate Discipline

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      No CAPA before validation

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      Threshold-to-action logic

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      Assessment - Classify mixed inputs with 95% accuracy

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      Identify all hidden assumptions in a deviation case

  3. 3

    Level 2 — Lead (System Integration Layer)

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      OpEx leaders and QA Managers

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      AEL Across Systems

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      Change control

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      Validation protocols

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      Supplier qualification

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      Traceability Architecture

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      Decision logs

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      Evidence mapping

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      Audit reconstruction

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      AI-HITL Workflow Design

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      Where AI is allowed vs blocked

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      Escalation logic

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      Assessment: Build a full AEL-governed workflow

  4. 4

    LEVEL 3 — Governance (Executive / Audit Layer)

    1. (Included in full purchase)

      Directors, Heads of Quality, Compliance

    2. (Included in full purchase)

      Systems Thinking in the complex regulated environment

    3. (Included in full purchase)

      Decision Governance Model

    4. (Included in full purchase)

      Audit Defense Simulation

    5. (Included in full purchase)

      AI Risk & Control (NIST-aligned)

    6. (Included in full purchase)

      Assessment: Defend a simulated FDA audit

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