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The Trainer
Jose Mora
Sr. Consultant, Streale |
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Venue and Date
Hyderabad - June 29, 2007
Time:
10:00 am - 5.30 pm |
| Who Will Benefit: |
This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers
- Project leaders implementing an electronic document system
- Functional managers
- QA managers
- Lean Project Managers
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Training Seminar on Applying Lean Principles to Controlled Documents
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “Training Seminar on Applying Lean Principles to Controlled Documents” by Jose Mora, Jose Mora is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC. Although he has been in the medical device industry for 24+ years in various companies, he has observed that the same types of issues and principles apply in all cases. Jose has worked as a Director of Manufacturing, Director of Manufacturing Engineering, Sr. Manufacturing Engineer, and as a Quality Systems Manager at companies such as V. Mueller (Cardinal Health), Cordis Corporation (J&J), Mentor Corporation, UroSurge (a startup urology products company), Boston Scientific, as well as several consulting clients.
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 lifescience 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 training presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance.
Outline of Conference
| MORNING SESSION - 10:00 AM - 1:30 PM |
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LEAN DOCUMENTS AND DOCUMENT CONTROL
Description
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 lifescience 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 training presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance.
Areas Covered in the seminar
- 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
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What Attendee Will Learn
- 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
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| AFTERNOON SESSION - 2:30 PM - 5:30 PM |
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APPLYING LEAN DOCUMENTS TO A PROJECT -
how to create a project file, follow design controls, yet maintain a lean set of project documents
Description
This training seminar explains the use of lean document principles and presents a step-by-step approach to creating a Design History File, a Device Master Record, and other key supporting documents. Typically, these records and their supporting documents contain many cross-references, duplicate information, and multi-functional documents which increase the chance of errors and other incorrect or imprecise information. Using the lean document approach, documents are written by the authors with the highest level of expertise, and information is presented in a simple, organized way.
Areas Covered in the seminar
- Creating a Lean Discovery Phase Document
- Creating a Lean Definition Phase Document
- Creating a Lean Requirements Phase Documents
- Creating a Lean Design Phase Document
- Creating Lean Build Phase Documents
- Creating Lean Test Phase Documents
- Creating Lean Transition Phase Documents
| What will students Learn
- How to keep a Design History File lean
- How to keep Design History documents lean
- How to cross-reference while keeping duplication minimal
- How to avoid the use of "smart numbers"
- How to avoid unnecessary duplication of information
- Creating single-function documents
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