An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know

Overview:

In today’s life sciences environment, document control is often where “lean” quietly breaks down. Teams may be moving quickly in manufacturing, labs, and operations—but controlled documentation can still create delays through long review cycles, repeated rework, and hidden dependencies that slow changes and drive up costs. When documents can’t move forward because they’re waiting on information, approvals, or resolution elsewhere in the system, the result isn’t just inefficiency—it’s a compliance posture that feels fragile, where energy goes into maintaining paperwork instead of producing clear, objective evidence.

This training focuses on how lean documentation principles can be applied across the full product and quality system lifecycle, with practical clarity on what makes a controlled document “lean” versus structurally non-lean. The session stays grounded in the DHF, DMR, and DHR constructs most organizations use day-to-day, while showing how the same thinking maps cleanly to modern risk-based quality system expectations reflected in ISO 13485 and the FDA’s Quality Management System Regulation (QMSR). The goal is not to re-teach terminology or force a reframe overnight, but to strengthen how documentation is built, flows, and holds up under real operational pressure.

Rather than focusing on tools or software, the webinar looks upstream—at document intent, information flow, constraints, and configuration logic. Participants will learn to identify where waste is structurally created in documentation systems, how to separate document content problems from configuration problems, and how lean thinking and Theory of Constraints can be applied to DHF/DMR/DHR structures in a way that remains compatible with current and emerging regulatory expectations. The outcome is a documentation approach that supports the business and enables improvement, instead of becoming an obstacle to change.

Areas covered in the session:

• Definition of lean documents and lean configuration principles
• Structural problems with traditional document approaches
• Applying lean manufacturing principles to documentation systems
• Applying Theory of Constraints to document flow and dependencies
• DHF, DMR, and DHR: intent, structure, and common failure modes
• Mapping lean documentation concepts to risk-based quality system expectations (high level)
• Typical documentation challenges and how to overcome them
• Examples of lean and non-lean controlled documents
• How traditional document structures generate waste and delay
• What a lean document system must have to remain scalable
• Creating lean DHF, DMR, and DHR structures without redefining roles or terminology
• Preparing to configure an electronic document system by addressing upstream structure, ownership, traceability signals, and configuration logic (principles-level, tool-agnostic)

Why should you attend?

If document updates in your organization feel slower than the work itself, this session will help you pinpoint why. You’ll learn how delays, rework, and excessive review cycles often come from the structure of the documentation system—not just the content—and how to spot the hidden dependencies that keep documents from moving forward.

You’ll also walk away with a practical way to apply lean thinking and Theory of Constraints to the DHF, DMR, and DHR your teams already use, without turning the webinar into a terminology overhaul. The focus is on creating documentation that produces clear, objective evidence and stays in a state of control while still allowing timely improvements.

Finally, if you’re planning to implement or refine an eDMS/eQMS, this webinar helps you get the “upstream” pieces right first—document intent, ownership, traceability signals, and configuration logic—so you don’t embed structural debt into the system and pay for it later through ongoing inefficiency and avoidable compliance strain.

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education—such as a QMSR/ISO-aligned terminology bridge and a document-control readiness template—to aid your teams in post-session implementation.

Who will benefit?

This webinar is useful for professionals responsible for documentation structure, document control performance, and quality system readiness; those include:

• VP/Director of Quality
• Head of Quality Assurance / QA Manager
• Quality Systems Manager / Quality Systems Engineer
• Document Control Manager / Document Control Lead
• Documentation Manager / Technical Documentation Lead
• Design Controls Manager / Design Assurance Manager
• Regulatory Affairs Manager (MedTech)
• Change Control / Configuration Management Lead
• eQMS / eDMS System Owner or Administrator
• Continuous Improvement / Operational Excellence Lead
• Internal Audit / Quality Audit Lead