Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

Why Should You Attend:

If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing, you as a manager need to be looking for ways to simplify their work.

This webinar will present a new approach that is based on solid principles and proven practices.

Areas Covered in the Webinar:

• Brief introduction to lean documents and lean configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together

Who Will Benefit:

This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control

Instructor Profile:

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, Jose 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 controlled documents and a template for strategic deployment.