5 Top Ranking Webinars on Principles of Lean Documents and Lean Configuration

This webinar package presents a new approach based on solid principles and proven practices. Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls require tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences. In this Lean Documents and Document Control training we learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents, pros and cons of lean vs. non-lean documents. This webinar series will also present a fresh new approach on applying lean principles to instituting corrective and preventive actions.
Instructor: Howard T Cooper, José Ignacio Mora
Product ID: PACK70031

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Quality personnel moving between FDA Regulated Industries
  • Quality personnel desiring to advance and grow in responsibilities
  • Management, Regulatory Affairs, Purchasing, Finance & Cost Accounting
  • Lean Project Managers
  • Research and Development
  • Leaders and Managers Responsible for Managing and that Regulatory Functions such as Environmental Pollution Agency (EPA), Drug Enforcement Agency (DEA)
  • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Operations
  • Document Control
  • Design Engineers, Manufacturing Engineers, Operations Managers, Quality System Managers, and Document Control Managers
  • Functional Managers
  • QA Managers

Webinars included in the Package:

Designing and Implementing the Quality System from Scratch (Duration: 90 Minutes)

This presentation will provide considerable insight into how quality systems are constructed and operated to meet customer requirements. If you face the challenge of setting up a new quality system, you will learn how to prevent most of the pitfalls if not all of the major showstoppers during preapproval inspection of the facility by the FDA or a client company. If you are not faced with this challenge, you will gain insight on how to actualize product and quality system improvements, and to mitigate quality problems.

Objectives of the Presentation:

  • Provide insight for the planning, developing, and implementation of quality systems
  • Discuss success factors
  • Define the quality system based on the product and quality process lifecycles
  • Describe the intricate planning process
  • Provide a roadmap that organizes the task and their sequence in designing and building process
  • Describe how continuous product and process improvement increase organizational efficiency and effectiveness
  • Demonstrate the commonality of all quality systems
  • Provide insight to expedite the development and implementation of the quality system.

Instructor Profile:

Howard T Cooper has over 40 years' experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration (Duration: 60 minutes)

If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, 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.

Objectives of the Presentation:

  • 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
  • Traceability Matrix
  • Applying lean document and lean configuration principles to the above
  • Bringing it all together

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration (Duration: 90 minutes)

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 presents a new approach based on solid principles and proven practices.

Objectives of the Presentation:

  • 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

An Advanced course on Lean Documents and Document Control (Duration: 90 minutes)

This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance. It will help you understand applying lean manufacturing principles, theory of constraints, DHF, DMR, DHR and how to create a lean DHF, DMR, DHR.

Objectives of the Presentation:

  • Definition of lean documents
  • Problems with traditional document approach
  • Applying lean manufacturing principles
  • Applying theory of Constraints
  • Design History File
  • Device Master Record
  • Device History Record
  • Typical challenges and how to overcome them
  • Examples of various types of lean documents
  • Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents
  • How traditional document approach generates waste
  • Clues from Theory of Constraints and Lean Manufacturing
  • What a lean document approach would have
  • Creating a lean Design History File
  • Creating a lean Device Master Record
  • Creating a lean Device History Record
  • Preparing for an electronic document system.

Corrective and Preventive Action utilizing the principles of Lean Documents and Lean Configuration (Duration: 90 minutes)

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Objectives of the Presentation:

  • Brief introduction to Lean Documents and Lean Configuration
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to Corrective and Preventive Action
  • Alignment of the Six Sigma DMAIC approach to CAPA
  • Applying lean principles to documenting and tracking non-conformances
  • Applying lean principles to investigating and resolving non-conformances
  • Applying lean principles to instituting corrective and preventive actions

Instructor Profile:

José 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.

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