Instructor :
Jose Mora

Webinar ID:
11808

In the life sciences industry, maintaining a compliant Quality Management System (QMS) is not just a requirement—it’s critical to ensuring the integrity of your operations and compliance with FDA regulations.

A major component of QMS is managing controlled documents and objective evidence through records, especially in manufacturing plants where each step of production must be documented and controlled.

For manufacturing plants, the challenge is even greater. Every step—from work instructions to SOPs, set-up instructions, equipment maintenance, and support functions—requires accurate documentation and must be backed by controlled records.

Compliance with these requirements is non-negotiable, but the complexity of traditional document systems often holds companies back from achieving the efficiency they need.

Historically, many life sciences companies have relied on overly complex, manual document numbering systems and paper-based processes. These outdated methods have persisted even with the shift to digital systems, leading to a situation where automation’s full potential is not being realized.

In fact, 99.9% of life sciences companies are still constrained by legacy policies and inefficient document systems, which were designed for a manual world but now hinder the capabilities of modern digital tools.

This is where we come in.

• • In this webinar, you’ll learn how to apply the Theory of Lean Documents and its corollary, the Theory of Lean Configuration, to revitalize your controlled document system.
  • We’ll show you how to streamline your documentation processes, eliminate unnecessary complexity, and leverage automation for maximum efficiency and compliance.

Whether you’re dealing with manufacturing work instructions, SOPs, or quality records, this webinar will equip you with the tools you need to ensure your documentation system is lean, effective, and compliant with FDA requirements.

What You’ll Learn:

• • How to apply Lean principles to reduce the complexity of your controlled document system
  • Strategies for optimizing SOPs, work instructions, and equipment maintenance records
  • How to overcome legacy policy constraints and fully realize the benefits of automation
  • Practical steps to ensure your document system is audit-ready and FDA-compliant
  • Methods for streamlining document configuration for enhanced efficiency and compliance

By the end of this webinar, you’ll have a fresh approach to your document systems that eliminates complexity, reduces errors, and ensures full compliance with the latest industry standards.

Join Now!

In the life sciences industry, maintaining a compliant Quality Management System (QMS) is not just a requirement—it’s critical to ensuring the integrity of your operations and compliance with FDA regulations.

A major component of QMS is managing controlled documents and objective evidence through records, especially in manufacturing plants where each step of production must be documented and controlled.

For manufacturing plants, the challenge is even greater. Every step—from work instructions to SOPs, set-up instructions, equipment maintenance, and support functions—requires accurate documentation and must be backed by controlled records.

Compliance with these requirements is non-negotiable, but the complexity of traditional document systems often holds companies back from achieving the efficiency they need.

Historically, many life sciences companies have relied on overly complex, manual document numbering systems and paper-based processes. These outdated methods have persisted even with the shift to digital systems, leading to a situation where automation’s full potential is not being realized.

In fact, 99.9% of life sciences companies are still constrained by legacy policies and inefficient document systems, which were designed for a manual world but now hinder the capabilities of modern digital tools.

This is where we come in.

• • In this webinar, you’ll learn how to apply the Theory of Lean Documents and its corollary, the Theory of Lean Configuration, to revitalize your controlled document system.
  • We’ll show you how to streamline your documentation processes, eliminate unnecessary complexity, and leverage automation for maximum efficiency and compliance.

Whether you’re dealing with manufacturing work instructions, SOPs, or quality records, this webinar will equip you with the tools you need to ensure your documentation system is lean, effective, and compliant with FDA requirements.

What You’ll Learn:

• • How to apply Lean principles to reduce the complexity of your controlled document system
  • Strategies for optimizing SOPs, work instructions, and equipment maintenance records
  • How to overcome legacy policy constraints and fully realize the benefits of automation
  • Practical steps to ensure your document system is audit-ready and FDA-compliant
  • Methods for streamlining document configuration for enhanced efficiency and compliance

By the end of this webinar, you’ll have a fresh approach to your document systems that eliminates complexity, reduces errors, and ensures full compliance with the latest industry standards.

Join Now!

• • Are you constantly frustrated by the complexity and inefficiency of your controlled document system?
  • Does your team spend more time managing redundant documentation than focusing on core manufacturing tasks?
  • Does it feel like your documentation is redundant, repetitive, and a time sink for your team?

If so, this webinar will offer you a fresh perspective and a game-changing approach to solve these issues.

If your controlled document system is stuck in a manual past, you’re likely losing time and increasing compliance risks in today’s regulated environment.

In many life sciences companies, valuable resources are tied up in maintaining overly complex document systems.

If your design and manufacturing teams are spending more time managing documents than focusing on what truly matters—designing and manufacturing—it’s time to rethink your approach.

This webinar will help you identify ways to simplify their workflow, allowing your team to be more productive, streamlined, and compliant with FDA regulations.

What sets this training apart is its focus on the Theory of Lean Documents and Lean Configuration—proven strategies that can revolutionize the way your organization handles controlled documentation.

You’ll learn how to eliminate unnecessary complexity, create audit-ready documents, and free your team to focus on their core tasks.

This isn’t just another theory-heavy session. It’s a practical, hands-on approach built on solid principles and real-world applications that you can start implementing immediately.

Don’t miss out on the chance to transform your documentation system and improve your overall efficiency and compliance.

Enroll Now!

• • Are you constantly frustrated by the complexity and inefficiency of your controlled document system?
  • Does your team spend more time managing redundant documentation than focusing on core manufacturing tasks?
  • Does it feel like your documentation is redundant, repetitive, and a time sink for your team?

If so, this webinar will offer you a fresh perspective and a game-changing approach to solve these issues.

If your controlled document system is stuck in a manual past, you’re likely losing time and increasing compliance risks in today’s regulated environment.

In many life sciences companies, valuable resources are tied up in maintaining overly complex document systems.

If your design and manufacturing teams are spending more time managing documents than focusing on what truly matters—designing and manufacturing—it’s time to rethink your approach.

This webinar will help you identify ways to simplify their workflow, allowing your team to be more productive, streamlined, and compliant with FDA regulations.

What sets this training apart is its focus on the Theory of Lean Documents and Lean Configuration—proven strategies that can revolutionize the way your organization handles controlled documentation.

You’ll learn how to eliminate unnecessary complexity, create audit-ready documents, and free your team to focus on their core tasks.

This isn’t just another theory-heavy session. It’s a practical, hands-on approach built on solid principles and real-world applications that you can start implementing immediately.

Don’t miss out on the chance to transform your documentation system and improve your overall efficiency and compliance.

Enroll Now!

• Introduction to Lean Documents and Lean Configuration
  • Gain a foundational understanding of the Lean principles and how they apply to controlled document systems in life sciences manufacturing.

• Overview of Quality System Regulation (QSR) and ISO Standards
  • Explore 21 CFR Part 820 and ISO 13485 regulations, with a focus on how they impact design control documents and compliance in the industry.

• Core Functions of a Life Sciences Manufacturing Plant
  • Understand the basic operational functions of a life sciences manufacturing plant, including key processes that rely on precise documentation.

• Types of Controlled Documents and Records for Manufacturing
  • Dive into the various controlled documents required for manufacturing, such as work instructions, SOPs, and maintenance records, and their role in compliance.

• Quality Management System (QMS) Documentation Elements
  • Learn about the essential QMS elements that are governed by documentation, ensuring compliance with FDA and ISO standards.

• Streamlining Document Management with Lean Principles
  • Discover how to reduce complexity and improve efficiency in your document management system using Lean Documentation principles.

• Automation vs. Legacy Policies: Overcoming Constraints
  • Understand how to overcome legacy policy constraints and unlock the full potential of automation for document management.

• Preparing for Audits with Lean Document Systems
  • Learn best practices to ensure your document system is audit-ready, minimizing risks and ensuring smooth FDA inspections.

• Bringing It All Together: Implementing Lean Configuration
  • See how all elements come together to form an effective, compliant controlled document system, applying the Theory of Lean Configuration in your operations.

BONUS:

• 1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

• Introduction to Lean Documents and Lean Configuration
  • Gain a foundational understanding of the Lean principles and how they apply to controlled document systems in life sciences manufacturing.

• Overview of Quality System Regulation (QSR) and ISO Standards
  • Explore 21 CFR Part 820 and ISO 13485 regulations, with a focus on how they impact design control documents and compliance in the industry.

• Core Functions of a Life Sciences Manufacturing Plant
  • Understand the basic operational functions of a life sciences manufacturing plant, including key processes that rely on precise documentation.

• Types of Controlled Documents and Records for Manufacturing
  • Dive into the various controlled documents required for manufacturing, such as work instructions, SOPs, and maintenance records, and their role in compliance.

• Quality Management System (QMS) Documentation Elements
  • Learn about the essential QMS elements that are governed by documentation, ensuring compliance with FDA and ISO standards.

• Streamlining Document Management with Lean Principles
  • Discover how to reduce complexity and improve efficiency in your document management system using Lean Documentation principles.

• Automation vs. Legacy Policies: Overcoming Constraints
  • Understand how to overcome legacy policy constraints and unlock the full potential of automation for document management.

• Preparing for Audits with Lean Document Systems
  • Learn best practices to ensure your document system is audit-ready, minimizing risks and ensuring smooth FDA inspections.

• Bringing It All Together: Implementing Lean Configuration
  • See how all elements come together to form an effective, compliant controlled document system, applying the Theory of Lean Configuration in your operations.

BONUS:

• 1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Regulatory Affairs Teams
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Design Assurance Teams
  • Device Development Teams
  • Personnel involved in Verification and Validation planning, execution and documentation for devices

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Regulatory Affairs Teams
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Design Assurance Teams
  • Device Development Teams
  • Personnel involved in Verification and Validation planning, execution and documentation for devices