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 Co Read more
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of
Course Objectives:
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
This webinar presents key concepts on introducing lean
Course Outline:
• 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
• 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 to configure an electronic document system.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable insights
• Design engineers
• Manufacturing engineers
• Operations managers
• Quality system managers
• Document control managers
• Project leaders implementing an electronic document system
• Functional managers
• QA managers
• Lean Project Managers
2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : Scheduled on
20-May-2024 :01:00 PM EDT
|
21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
LIVE : Scheduled on
30-May-2024 :01:00 PM EDT
|
6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on
18-June-2024 :11:00 AM EDT
|
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on
19-June-2024 :11:00 AM EDT
|
6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance, Complaint Handling, eMDR, Recalls, UDI Regulations & Emerging Signals
LIVE : Scheduled on
25-June-2024 :11:00 AM EDT
|