2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment
Stay Ahead or Pay the Price – Learn Cutting-Edge Strategies to Prevent Costly Compliance Mistakes!
Instructor :
Jose Mora
Webinar ID:
12145
Date: DEC 06, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
⚙️ The FDA Compliance & Validation Strategies Bundle (3 Courses)
“Optimize Your Processes and Ensure Compliance in FDA-Regulated Industries!”
Courses Included:
-
- 2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment (duration 90 mins.), find out more details here
- Compliance Chaos or Control? Master Change Control & Optimize Regulatory Assessments (duration 90 mins.), find out more details here
- Navigating FDA’s AI/ML Regulations: How to Stay Compliant as Your Systems Evolve? (duration 90 mins.), find out more details here
This Bundle Empowers You To:
-
- Enhance Process Validation: Implement effective validation strategies to meet FDA requirements.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
⚙️ The FDA Compliance & Validation Strategies Bundle (3 Courses)
“Optimize Your Processes and Ensure Compliance in FDA-Regulated Industries!”
Courses Included:
-
- 2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment (duration 90 mins.), find out more details here
- Compliance Chaos or Control? Master Change Control & Optimize Regulatory Assessments (duration 90 mins.), find out more details here
- Navigating FDA’s AI/ML Regulations: How to Stay Compliant as Your Systems Evolve? (duration 90 mins.), find out more details here
This Bundle Empowers You To:
-
- Enhance Process Validation: Implement effective validation strategies to meet FDA requirements.
- Master Change Control: Navigate the complexities of regulatory impact assessments during changes.
- Leverage Emerging Technologies: Understand FDA regulations concerning AI and ML to innovate responsibly.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy All 3 Courses at a 35% discount HERE
What will you learn
-
- Understand Global Harmonization Task Force, FDA, And ISO Requirements.
- Master Installation Qualification To Ensure Correct Equipment Installation.
- Learn Operational Qualification For Performance Under Real-World Conditions.
- Grasp Performance Qualification To Ensure Consistent, Effective Process Outcomes.
- Implement Design Qualification For Meeting Required Specifications Pre-Commissioning.
- Validate Facilities And Utilities Supporting Equipment For Reliable ….
-
- Understand Global Harmonization Task Force, FDA, And ISO Requirements.
- Master Installation Qualification To Ensure Correct Equipment Installation.
- Learn Operational Qualification For Performance Under Real-World Conditions.
- Grasp Performance Qualification To Ensure Consistent, Effective Process Outcomes.
- Implement Design Qualification For Meeting Required Specifications Pre-Commissioning.
- Validate Facilities And Utilities Supporting Equipment For Reliable Operations.
- Develop Robust Process Validation Strategies For Long-Term Reliability.
Course Description
In today’s increasingly stringent regulatory landscape, compliance is no longer just a requirement—it’s a strategic advantage.
Effective process validation goes beyond meeting minimum standards; it’s the cornerstone of process reliability, improved yields, and reduced operating costs.
This 90-minute, expert-led webinar delves into advanced strategies for 2025, equipping you with the tools to implement robust process validation systems that not only meet FDA and ISO standards but are also future-proof.
Our seasoned instructor will guide you through the latest global regulatory trends and provide practical, actionable insights to keep your operations ahead of the curve.
Key Benefits You’ll Gain:
-
- Master essential process validation requirements to meet and exceed 2025 regulatory expectations.
- Learn how to design validation processes that ensure consistent performance and operational reliability.
- Discover how effective process validation can reduce operational costs while increasing yields.
- Understand how to turn compliance challenges into competitive advantages by building stronger, more resilient systems.
By the end of this webinar, you’ll have the knowledge and tools to prevent costly compliance failures, optimize your processes, and protect your organization from regulatory risks.
Whether you work in pharmaceuticals, manufacturing, or any highly regulated sector, this webinar will provide you with advanced, actionable strategies to enhance your process validation approach.
You’ll walk away with proven techniques to ensure compliance and drive operational efficiency—making your organization audit-ready and globally aligned for the challenges of 2025
Don’t wait until it’s too late—join us to turn next year’s compliance challenges into your competitive advantage
Join Now!
In today’s increasingly stringent regulatory landscape, compliance is no longer just a requirement—it’s a strategic advantage.
Effective process validation goes beyond meeting minimum standards; it’s the cornerstone of process reliability, improved yields, and reduced operating costs.
This 90-minute, expert-led webinar delves into advanced strategies for 2025, equipping you with the tools to implement robust process validation systems that not only meet FDA and ISO standards but are also future-proof.
Our seasoned instructor will guide you through the latest global regulatory trends and provide practical, actionable insights to keep your operations ahead of the curve.
Key Benefits You’ll Gain:
-
- Master essential process validation requirements to meet and exceed 2025 regulatory expectations.
- Learn how to design validation processes that ensure consistent performance and operational reliability.
- Discover how effective process validation can reduce operational costs while increasing yields.
- Understand how to turn compliance challenges into competitive advantages by building stronger, more resilient systems.
By the end of this webinar, you’ll have the knowledge and tools to prevent costly compliance failures, optimize your processes, and protect your organization from regulatory risks.
Whether you work in pharmaceuticals, manufacturing, or any highly regulated sector, this webinar will provide you with advanced, actionable strategies to enhance your process validation approach.
You’ll walk away with proven techniques to ensure compliance and drive operational efficiency—making your organization audit-ready and globally aligned for the challenges of 2025
Don’t wait until it’s too late—join us to turn next year’s compliance challenges into your competitive advantage
Join Now!
Why you should attend
“Process validation is no longer just about checking boxes to satisfy compliance requirements—it’s a strategic necessity for staying competitive.”
Without a solid process validation strategy, you risk costly compliance violations, operational inefficiencies, and missed opportunities for improvement.
This 90-minute webinar will empower you to turn process validation into a value-driven asset for your organization. You’ll learn practical, real-world strategies that go beyond mere compliance and focus on achieving process reliability, improved yields, and cost savings.
Whether you’re a Regulatory Affairs Manager, Quality Assurance Professional, or Process Engineer, the skills gained here will help you solve pressing challenges in your daily role.
Here’s Why You Can’t Miss This Webinar:
-
- Stay compliant in a rapidly changing regulatory environment by mastering the latest process validation requirements.
- Boost your operational efficiency by learning how to design and implement validation protocols that ensure consistent performance.
- Prevent costly compliance errors with insights that enable you to anticipate and mitigate potential pitfalls before they occur.
- Turn process validation into a competitive advantage by leveraging it for better yields and reduced operating costs.
By attending this webinar, you’ll be equipped with the latest industry insights and best practices to not only meet compliance demands but also optimize your processes, making you a key asset in your organization’s success.
Join Now!
“Process validation is no longer just about checking boxes to satisfy compliance requirements—it’s a strategic necessity for staying competitive.”
Without a solid process validation strategy, you risk costly compliance violations, operational inefficiencies, and missed opportunities for improvement.
This 90-minute webinar will empower you to turn process validation into a value-driven asset for your organization. You’ll learn practical, real-world strategies that go beyond mere compliance and focus on achieving process reliability, improved yields, and cost savings.
Whether you’re a Regulatory Affairs Manager, Quality Assurance Professional, or Process Engineer, the skills gained here will help you solve pressing challenges in your daily role.
Here’s Why You Can’t Miss This Webinar:
-
- Stay compliant in a rapidly changing regulatory environment by mastering the latest process validation requirements.
- Boost your operational efficiency by learning how to design and implement validation protocols that ensure consistent performance.
- Prevent costly compliance errors with insights that enable you to anticipate and mitigate potential pitfalls before they occur.
- Turn process validation into a competitive advantage by leveraging it for better yields and reduced operating costs.
By attending this webinar, you’ll be equipped with the latest industry insights and best practices to not only meet compliance demands but also optimize your processes, making you a key asset in your organization’s success.
Join Now!
Areas Covered
-
- Global Harmonization Task Force (GHTF) Requirements
Learn the key regulatory requirements from both the FDA and ISO standards, ensuring global compliance for process validation. - Installation Qualification (IQ)
Understand how to verify and document that your equipment and systems are installed correctly and meet specified installation requirements. - Operational Qualification (OQ)
Explore the steps to ensure your equipment operates within the defined operational parameters under real-world conditions. - Performance Qualification (PQ)
Discover how to demonstrate that systems and processes perform consistently and effectively under normal operating conditions. - Design Qualification (DQ)
Learn how to validate that the design of equipment, systems, and processes meets the required specifications before commissioning. - Facilities and Utilities
Understand the importance of validating the facilities and utilities that support your equipment and processes to ensure reliable outcomes. - Strategies for Achieving a Robust and Reliable Process
Gain practical insights into designing and implementing a robust process validation strategy that improves process reliability and performance. - Typical Process Validation Protocols
Review real-world examples of typical process validation protocols, providing a clear framework for developing your own protocols.
- Global Harmonization Task Force (GHTF) Requirements
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Global Harmonization Task Force (GHTF) Requirements
Learn the key regulatory requirements from both the FDA and ISO standards, ensuring global compliance for process validation. - Installation Qualification (IQ)
Understand how to verify and document that your equipment and systems are installed correctly and meet specified installation requirements. - Operational Qualification (OQ)
Explore the steps to ensure your equipment operates within the defined operational parameters under real-world conditions. - Performance Qualification (PQ)
Discover how to demonstrate that systems and processes perform consistently and effectively under normal operating conditions. - Design Qualification (DQ)
Learn how to validate that the design of equipment, systems, and processes meets the required specifications before commissioning. - Facilities and Utilities
Understand the importance of validating the facilities and utilities that support your equipment and processes to ensure reliable outcomes. - Strategies for Achieving a Robust and Reliable Process
Gain practical insights into designing and implementing a robust process validation strategy that improves process reliability and performance. - Typical Process Validation Protocols
Review real-world examples of typical process validation protocols, providing a clear framework for developing your own protocols.
- Global Harmonization Task Force (GHTF) Requirements
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Managers who need to stay updated on evolving compliance standards and avoid costly regulatory violations.
- Quality Assurance Professionals looking to ensure process consistency and reduce the risk of non-compliance through effective validation strategies.
- Operations Managers seeking to improve process efficiency and optimize production workflows while maintaining full regulatory compliance.
- Process Engineers tasked with designing and validating reliable, repeatable processes that enhance performance and minimize errors.
- Compliance Officers responsible for mitigating compliance risks and ensuring processes meet both FDA and ISO standards.
- Manufacturing Supervisors who need practical solutions to boost yields, reduce operational downtime, and ensure smooth process execution.
- Product Development Teams striving to validate new product processes efficiently, ensuring compliance from design through production.
- Training and Development Heads wanting to provide their teams with actionable strategies for mastering process validation and boosting productivity.
- HR Professionals focused on developing training programs that help employees stay compliant with industry regulations and increase operational expertise.
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Managers who need to stay updated on evolving compliance standards and avoid costly regulatory violations.
- Quality Assurance Professionals looking to ensure process consistency and reduce the risk of non-compliance through effective validation strategies.
- Operations Managers seeking to improve process efficiency and optimize production workflows while maintaining full regulatory compliance.
- Process Engineers tasked with designing and validating reliable, repeatable processes that enhance performance and minimize errors.
- Compliance Officers responsible for mitigating compliance risks and ensuring processes meet both FDA and ISO standards.
- Manufacturing Supervisors who need practical solutions to boost yields, reduce operational downtime, and ensure smooth process execution.
- Product Development Teams striving to validate new product processes efficiently, ensuring compliance from design through production.
- Training and Development Heads wanting to provide their teams with actionable strategies for mastering process validation and boosting productivity.
- HR Professionals focused on developing training programs that help employees stay compliant with industry regulations and increase operational expertise.
Instructor Profile
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, orthopedic 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.
