The Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR) are core building blocks for medical device design, manufacturing and cGMP compliance. Too often they become cluttered and confusing, and the way they are built and managed leads to errors.
This 60-minute DHF, DMR and DHR training applies the Theory of Lean Documents, and a matching Theory of Lean Configuration, to these records. You'll review what the Quality System Regulation, 21 CFR Part 820, expects of each, then see how to create, develop and manage each file using lean principles.
The result is an alternative to traditional methods that avoids many of their pitfalls.
If creating and maintaining DHFs, DMRs and DHRs is a constant struggle, with information repeated and chained together in awkward ways, this webinar offers a different approach based on solid principles and proven practice. It helps design and manufacturing teams spend less time on paperwork and more on engineering.
It suits R&D, manufacturing engineering, quality assurance, operations and document control staff.
If creating and maintaining DHFs, DMRs and DHRs is a constant struggle, with information repeated and chained together in awkward ways, this webinar offers a different approach based on solid principles and proven practice. It helps design and manufacturing teams spend less time on paperwork and more on engineering.
It suits R&D, manufacturing engineering, quality assurance, operations and document control staff.
Jose Ignacio Mora
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of …
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