Overview:
In
today's fast-paced life sciences industry, many companies struggle with
cumbersome controlled document systems that generate significant operating
expenses and hinder timely process improvements. Just as a manufacturing
process produces a product, controlled documents are the product of a business
process. These documents can become bottlenecks, delaying crucial operations if
they are waiting for information or constrained by other documents. This often
leads to operational inefficiencies, increased costs, and delays in
time-to-market for critical products.
Professionals
in the field frequently encounter challenges such as slow document processes
and the inability to implement timely process improvements due to the burden of
maintaining regulatory compliance. The traditional approach to documentation
can result in significant waste, with extensive time and resources spent on
managing and updating documents, rather than focusing on core operational
activities. Furthermore, ensuring that all documentation meets stringent
regulatory standards while also adhering to lean principles can be particularly
daunting, creating a significant barrier to achieving streamlined operations.
This
advanced webinar addresses these pressing issues by presenting key concepts on
introducing lean principles while maintaining control and compliance. You will
learn how to apply lean manufacturing principles, the theory of constraints,
and streamline your Design History File (DHF), Device Master Record (DMR), and
Device History Record (DHR) to create efficient, lean documentation systems.
The session will offer practical insights into overcoming common challenges,
such as high operational costs and regulatory hurdles, by implementing lean
documentation practices that enhance efficiency and reduce waste.
By
attending this webinar, you will gain the knowledge needed to transform your
document control processes, achieving a more streamlined and effective
operation. Whether you are struggling with slow document turnaround times,
facing high operational expenses, or finding it difficult to comply with
regulatory requirements, this webinar will equip you with the tools and
strategies necessary to address these pain points and drive significant
improvements in your documentation processes. Join us to learn how to create a
lean, compliant, and efficient documentation system that supports your business
goals.
Areas
Covered in the Session:
- 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
to configure an electronic document system.
Why
you should attend?
Attending
this webinar will provide you with essential insights and practical strategies
to revolutionize your document control processes. If you are struggling with
slow document turnaround times, high operational costs, or complex regulatory
compliance requirements, this session is designed for you. Learn how to
streamline your documentation processes using lean principles, significantly
reducing delays and improving overall efficiency.
Discover
how implementing lean documentation practices can help you cut down on
unnecessary expenses and ensure your documentation meets all necessary
regulatory standards without added complexity. With real-world examples and
actionable steps, this webinar will equip you with the knowledge to transform
your documentation system into a streamlined and efficient operation,
supporting your business goals and enhancing overall productivity. Don't miss
this opportunity to benefit from expert guidance and drive significant
improvements in your documentation processes.
Industries
that would benefit from this webinar include:
- Pharmaceutical
Companies
- Medical
Device Manufacturers
- Biotechnology
Firms
- Healthcare
Providers
- Laboratory
Services
- Food
and Beverage Manufacturers
- Cosmetic
Manufacturers
- Any
organization within the life sciences sector aiming to implement lean
documentation principles.
Who
Should Attend?
This
webinar is ideal for professionals in the life sciences industries who are
involved in document control, regulatory compliance, and process improvement.
Specific job titles and designations that would benefit from this webinar
include:
- Quality
Assurance Managers
- Regulatory
Affairs Specialists
- Document
Control Managers
- Process
Improvement Managers
- Compliance
Officers
- Manufacturing
Engineers
- Quality
Control Analysts
- Operations
Managers
- R&D Managers
- Project Managers
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. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Enrollment Options
Tags: Lean Documentation, Document Control, Regulatory Compliance, Lean Manufacturing, Quality Assurance, Process Improvement, Life Sciences, Pharmaceutical, Medical Device, Biotechnology, Healthcare, Document Management, Jose Mora, August 2024, Webinar