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34594 Conferences

Controlled Document System for Life Sciences manufacturing plant - principles of Lean Documents and Lean Configuration

Added by OCPcompliance on 2014-09-16

Conference Dates:

Start Date Start Date: 2014-11-04
Last Date Last Day: 2014-11-04
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2014-11-04

Conference Contact Info:

Contact Person Contact Person: David Jonathan Moses
Email Email:
Address Address: 38868 Salmon Ter, Fremont, CA, 94536, United States
Phone Tel: +1-510-857-5896
Phone Fax: +1-510-509-9659

Conference Description:

Instructor: Angela Bazigos

This webinar explains about Controlled Document System for Life Sciences manufacturing plant - principles of Lean Documents and Lean Configuration in Manufacturing.

This session will also explain why continuing use of current document control will prevent a manufacturing plant from fully realizing the benefits of lean manufacturing principles. It will also show how 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. Examples of lean and non-lean controlled documents, pros and cons of lean vs. non-lean documents will be discussed.

Why Should you Attend:
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner. This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Objectives of the Presentation:
Definition of lean documents.
What’s wrong with traditional document approach?
Theory of Constraints and Lean Manufacturing.
Applying lean manufacturing principles to Document Control
Applying Theory of Constraints.
Examples of various types of lean documents are Design History File, Device Master Record, and Device History Record.
Typical challenges and how to overcome them.
Preparing for an electronic document system.

Who can Benefit:
Design engineers
Manufacturing engineers
Operations managers
Quality Control
Quality Assurance
Document control managers
IT implementing electronic document system
Lean project managers
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