Lean Document Control for Manufacturing in Life Sciences

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Lean Manufacturing for Reducing Costs and Increasing Product Output

Lean Manufacturing is increasingly being used in Life Sciences as a way to reduce costs and increase product output without impacting product quality. Documentation drives the processes in any manufacturing plant. Consequently, lean documentation and lean document control speeds up and enhances implementation of lean manufacturing.

Just as manufacturing process produces a product, controlled documents are the product of a business process. In manufacturing, a product cannot move forward if it is waiting for component parts, similarly, a document cannot move forward if it’s waiting for information, or if its use is constrained by other documents. Even though many life science companies advocate lean manufacturing, lean laboratory and lean operations, they often have cumbersome controlled documents and systems which cause significant operating expenses, and make it hard to introduce process improvements in a timely manner. In this session, you will learn how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

This 90-minute session with Angela Bazigos will explain the different types of documents and the usage of lean document principles in Manufacturing. She will describe why continuing to use current document control will prevent a manufacturing plant from fully realizing the benefits of lean manufacturing principles. Know how the use of Lean Documents and Lean Document Control will enable Manufacturing Operations to meet Lean Manufacturing Principles to reduce production costs without impacting product quality, and remaining compliant with regulatory authority expectations. Get heaps of examples on lean and non-lean controlled documents, difference between lean vs. non-lean documents, and more!

Areas covered in the topic:

  • Definition of lean documents
  • What’s wrong with traditional document approach?
  • Insights on theory of Constraints and Lean Manufacturing
  • Applying lean manufacturing principles to Document Control
  • Applying Theory of Constraints
  • Learn from the examples of various types of lean documents
    • Design History File
    • Device Master Record
    • Device History Record
  • Learn from the typical challenges and how to overcome them
  • Know how to prepare for an electronic document system

Who should attend

  • Design engineers
  • Manufacturing engineers
  • Operations managers
  • Purchasing
  • Quality Control
  • Quality Assurance
  • Document control managers
  • IT implementing electronic document system
  • Lean project managers

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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
More Events By The Speaker

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